Try our Chrome extension
Easily add the current web-page from your browser directly into your changedetection.io tool, more great features coming soon!
Chrome Webstore
Changedetection.io needs your support!
You can help us by supporting changedetection.io on these platforms;
- Rate us at AlternativeTo.net
- Star us on GitHub
- Follow us at Twitter/X
- G2 Software reviews
- Check us out on LinkedIn
- And tell your friends and colleagues :)
The more popular changedetection.io is, the more time we can dedicate to adding amazing features!
Many thanks :)
changedetection.io team
Not yet seconds ago
False
Not yet seconds ago
2 hours ago
| Skip to main content Contact Us × You must have JavaScript enabled to use this form. Full Name Business Email Contact Number Message How did you hear about us? - Select -Search EngineE-mail CampaignGoogle AdsSocial MediaLink from another websiteColleague’s RecommendationNewsletterPrinted BrochureOther Other (Please specify) I have read the privacy policy Submitted Page URL Website URL Content Type Form Name Leave this field blank What are you looking for? × Search Get in Touch × You must have JavaScript enabled to use this form. Name Company Business Email Contact Number Message How did you hear about us? - Select -Search EngineE-mail CampaignGoogle AdsSocial MediaLink from another websiteColleague’s RecommendationNewsletterPrinted BrochureOther Other (Please specify) I have read the privacy policy Submitted Page URL Content Type Website URL Form Name Leave this field blank Consult × * Test Drive , our AI Chatbot - get instant regulatory answers, free and live! * Try Now . * Get in Touch * * * * * Home * Solutions + Back + Solutions + Medicinal Products o Back o Medicinal Products Regulatory Services Regulatory Affairs Regulatory Operations Regulatory Medical Writing Regulatory Pharmacovigilance Medical and Scientific Communication Compliance, Audit, and Validation Regulatory Artwork Solutions Global Regulatory Intelligence - MPR - Regulatory Affairs Menu Block * Market Access with end-to-end Regulatory Solutions * Drug Development Regulatory Services * Regulatory Strategy and Insights * Dossier Authoring * Post Approval/Lifecycle Management * Country-specific Regulatory Services * Global Health Authorities-Specific Services * EU CTR Submissions - MPR - Regulatory Operations Menu * Regulatory Publishing and Submissions * Regulatory Labeling Services - MPR - Medical Writing Menu Block * Clinical Services * Non-Clinical Writing Services * Regulatory Toxicology Services * Clinical and Non-Clinical Consulting and Strategic Services * Automation in Medical Writing - MPR - Pharmacovigilance Menu Block * Medical Literature Monitoring * Individual Case Safety Report * Aggregate Safety Reports * Pharmacovigilance Risk Management Plan * Pharmacovigilance (PV) Signal Detection Services * Pharmacovigilance (PV) Audit Services * Quality Control in Pharmacovigilance * Qualified Person for Pharmacovigilance * Regulatory Intelligence in Pharmacovigilance * Pharmacovigilance (PV) Safety Database Services & Solutions - MPR - Medical & Scientific Communication Menu Block * Medical Copywriting Services * Medical and Scientific Writing Services * Manuscripts and Publications * Creative Scientific Design Studio * Promotional Materials MLR Review * Medical and Scientific Content Management * FDA Ad Promo Submission Services - OPDP 2253 - MPR - Compliance and Audit Services Menu Block * Pharma Quality and Compliance Services * SOP Writing and SOP Review Services * Pharma GxP Audit Services * Pharma CSV and CSA Services * QMS Remediation and Establishment Services * End-to-end Regulatory Compliance Services - MPR - New Regulatory Artwork Solutions Menu Block * Regulatory Artwork Services MPR - Artwork Menu Block * Artwork Graphic Studio * Artwork Proofreading * Global Artwork Translation * Artwork Process Consultancy * Printed Packaging Print-Proof Quality Check * e-Leaflet and e-Label * Content to Carton * Artwork Lifecycle Coordination - MPR - GRI Menu Blocks * Global Regulatory Intelligence + Medical Devices o Back o Medical Devices Regulatory Services Digital Health / SaMD Market Access Post Market Surveillance EU Compliance Clinical & Performance Evaluation Quality, Compliance, & Audit Artwork Services Regulatory Affairs Global Regulatory Intelligence - MDV - Digital Health/SaMD services menu block * SaMD Registration in the US * SaMD Registration in the EU * Global Market Expansion for SaMD * Regulatory Strategy Consultation for SaMD * Quality Management Systems Implementation - MDV - Market Access menu block * Device Registration Americas * Device Registration Europe * Device Registration China * Device Registration South Korea * Device Registration Australia * Device Registration UK * Device Registration Switzerland * Device Registration: Rest of the World * In-Country Representation - MDV - Post Market Surveillance Menu Block * Product Complaints Management * Device Recall, Corrections and Removals * PMSP, PMSR, PMCF, PSUR, Annual Maintenance * Health Hazard Evaluation * Medical Device Translation Services - EU Compliance MDV menu Block * CE Marking * EU MDR * EU IVDR * European Authorized Representative - MDV Medical Writing Services Menu Block * Clinical Evaluation * Performance Evaluation * Lifecycle Management * Literature Search Protocol and Review - MDV - Quality Management System services menu block * QMS Consultancy Services * ISO 14971 Risk Management Consulting * QMS Remediation * Compliance & Audit Support * QMS Toolkit * Document Management * Corrective and Preventive Action Management Services * Supplier Evaluation - MDV - new Artwork Services menu Block * Regulatory Artwork - MDV - Regulatory affairs services menu block * Device Documentation * Labeling Services * Technical Writing Services * RA Staff Augementation Services * Regulatory Consulting * Human Factors Engineering for Medical Devices * Market Intelligence Service * Medical and Scientific Communication * Mergers and Acquisitions Regulatory Services * Biocompatibility Services for Medical Devices - MDV - GRI Menu Blocks * Global Regulatory Intelligence + Cosmetics o Back o Cosmetics Regulatory Services COS - Cosmetics services1 Menu - Cosmetic Product Labeling Review - Cosmetic Safety Assessment and Toxicology Services - Global Regulatory Compliance and Consulting (GRCC) - Formulation and Ingredient Review - Cosmetic Product Information File (PIF) - Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) - Go-to-market and Legal Representative (LR) - EUDR Compliance Services for Cosmetics Industry COS - Cosmetics services2 Menu - Comprehensive Artwork Services for Cosmetics - Global Cosmetovigilence Services - Claims Review - Cosmetic Testing - Cosmetic Regulatory Intelligence - Global Regulatory Intelligence + Food Supplements o Back o Food Supplements Regulatory Services Food Product Service FDS - Food Product Service menu - Food & Food Supplements Product Services - Food and Food Supplements Artwork Services - Global Regulatory Compliance and Consulting (GRCC) - Novel Food Support (NDIN, GRAS, NSF) - Raw Material Specification Compliance - Ingredients/Formulation Compliance - Claims Review, Substantiation, and Notification Support - Food and Food Supplement Classification: A Global Overview - Manufacturing Facility Registration Support (FFR/FBO/Site license) - Labeling Compliance - Dossier Compilation Support - Food Product Registration Service/Notification - Legal Representation (LR) Support - Regulatory Audit and Training Support (GMPs, GHP, HACCP) - Food Regulatory Pathway Reports Food Product Compliance FDS - Food Product Compliance Menu - Sustainability Services - Recycling Logo Content and Design Support for Food and Food Supplements - Navigate EPR, PCR, PPWR & SUP Compliance with Confidence! - EU Deforestation Regulation Services - Ecolabelling Regulatory Support Novel Food Registration + Chemicals o Back o Chemicals Regulatory Services CSRA - Chemicals service1 Menu - Chemical Data Scouting - Chemical Scientific Assessment Reports and Position Paper Report - Supply Chain Regulatory Compliance - Chemical Packaging Regulations - Global Biocidal Products Regulation Services - Regulation of Tobacco Products - Ecolabeling Regulatory Support - Chemical Safety Data Sheet (SDS) Authoring & Compliance Services - Household and Chemical Products Artwork Services - Sustainability Consulting Services CSRA - Chemicals service2 Menu - Extended Safety Data Sheet (eSDS) Services - Global Regulatory Compliance and Consulting (GRCC) - Pet Care Products Registration - General Product Safety Regulation (GPSR) - Global REACH Regulatory Compliance - Chemical Toxicological Risk Assessment - EUDR Compliance Services for Chemical & general consumer product - Environmental Risk Assessment (ERA) Services - Global Regulatory Intelligence + Spotlight o Back o Spotlight - EUDR Compliance | Food, Cosmetics & Chemicals - EUDR Knowledge Hub * Global + Back + Global + Americas o Back o Americas o Mobile Menu Americas - Argentina - Bolivia - Brazil - Canada - Chile - Colombia - Costa Rica - Dominican Republic - Guatemala - Mexico - Panama - Paraguay - Peru - Puerto Rico - United States - Venezuela + Europe o Back o Europe o Mobile Menu Eupope - Albania - Austria - Belarus - Belgium - Bulgaria - Croatia - Cyprus - Czech Republic - Denmark - Estonia - European Union - Finland - France - Germany - Greece - Hungary - Ireland - Italy - Kazakhstan - Kosovo - Latvia - Lithuania - Luxembourg - Macedonia - Malta - Netherlands - Norway - Poland - Portugal - Romania - Serbia - Slovakia - Slovenia - Spain - Sweden - Switzerland - United Kingdom - Uzbekistan + Asia - Pacific o Back o Asia - Pacific o Mobile Menu Asia - Pacific - Australia - Bangladesh - Cambodia - China - Hong Kong - India - Indonesia - Japan - Malaysia - New Zealand - Pakistan - Philippines - Singapore - South Korea - Sri Lanka - Taiwan - Thailand - Vietnam + Africa & Middle East o Back o Africa & Middle East o Mobile Menu Africa & Middle East - Algeria - Bahrain - Egypt - Ethiopia - Ghana - Iraq - Israel - Jordan - Kenya - Kuwait - Lebanon - Morocco - Nigeria - Qatar - Saudi Arabia - South Africa - Tunisia - Turkey - UAE - Uganda - Yemen - Zimbabwe * Customers + Back + Customers + Mobile Menu Customers o Success Stories o Case Studies o Testimonials * Insights + Back + Insights + Mobile Menu Insights o Blogs o Brochures o Infographics o Webinars o Freyr Podcasts o What is ...? o White Papers o Fireside Chats o e-Books o Global Health Authority Mandates o Regulatory Roundup o Templates and Checklists o Industry News o Videos o Toolkits * Company + Back + Company + Mobile Menu Company o About Us o Awards & Recognitions o Press Releases o Freyr in Media o Industry Events o Freyr Events o Careers o Compliance Wall o Corporate Social Responsibility o Functional Delivery Models o Partner with Us o Contact Us * Select Country + Japan Japanese | English + South Korea Korean | English + China Chinese | English + Mexico Español | English + Brazil Portuguese | English + Australia English + Sri Lanka English + India English + Malaysia English + Nigeria English + Saudi Arabia English + Thailand English * Solutions Toggle submenu Medicinal Products Medical Devices Consumer freya fusion Medicinal Products Regulatory Services Regulatory Affairs Regulatory Operations Regulatory Medical Writing Regulatory Pharmacovigilance Medical and Scientific Communication Compliance, Audit, and Validation Regulatory Artwork Solutions Global Regulatory Intelligence + MPR - Regulatory Affairs Menu Block o Market Access with end-to-end Regulatory Solutions o Drug Development Regulatory Services o Regulatory Strategy and Insights o Dossier Authoring o Post Approval/Lifecycle Management o Country-specific Regulatory Services o Global Health Authorities-Specific Services o EU CTR Submissions + MPR - Regulatory Operations Menu o Regulatory Publishing and Submissions o Regulatory Labeling Services + MPR - Medical Writing Menu Block o Clinical Services o Non-Clinical Writing Services o Regulatory Toxicology Services o Clinical and Non-Clinical Consulting and Strategic Services o Automation in Medical Writing + MPR - Pharmacovigilance Menu Block o Medical Literature Monitoring o Individual Case Safety Report o Aggregate Safety Reports o Pharmacovigilance Risk Management Plan o Pharmacovigilance (PV) Signal Detection Services o Pharmacovigilance (PV) Audit Services o Quality Control in Pharmacovigilance o Qualified Person for Pharmacovigilance o Regulatory Intelligence in Pharmacovigilance o Pharmacovigilance (PV) Safety Database Services & Solutions + MPR - Medical & Scientific Communication Menu Block o Medical Copywriting Services o Medical and Scientific Writing Services o Manuscripts and Publications o Creative Scientific Design Studio o Promotional Materials MLR Review o Medical and Scientific Content Management o FDA Ad Promo Submission Services - OPDP 2253 + MPR - Compliance and Audit Services Menu Block o Pharma Quality and Compliance Services o SOP Writing and SOP Review Services o Pharma GxP Audit Services o Pharma CSV and CSA Services o QMS Remediation and Establishment Services o End-to-end Regulatory Compliance Services + MPR - New Regulatory Artwork Solutions Menu Block o Regulatory Artwork Services MPR - Artwork Menu Block o Artwork Graphic Studio o Artwork Proofreading o Global Artwork Translation o Artwork Process Consultancy o Printed Packaging Print-Proof Quality Check o e-Leaflet and e-Label o Content to Carton o Artwork Lifecycle Coordination + MPR - GRI Menu Blocks o Global Regulatory Intelligence Medical Devices Regulatory Services Digital Health / SaMD Market Access Post Market Surveillance EU Compliance Clinical & Performance Evaluation Quality, Compliance, & Audit Artwork Services Regulatory Affairs Global Regulatory Intelligence + MDV - Digital Health/SaMD services menu block o SaMD Registration in the US o SaMD Registration in the EU o Global Market Expansion for SaMD o Regulatory Strategy Consultation for SaMD o Quality Management Systems Implementation + MDV - Market Access menu block o Device Registration Americas o Device Registration Europe o Device Registration China o Device Registration South Korea o Device Registration Australia o Device Registration UK o Device Registration Switzerland o Device Registration: Rest of the World o In-Country Representation + MDV - Post Market Surveillance Menu Block o Product Complaints Management o Device Recall, Corrections and Removals o PMSP, PMSR, PMCF, PSUR, Annual Maintenance o Health Hazard Evaluation o Medical Device Translation Services + EU Compliance MDV menu Block o CE Marking o EU MDR o EU IVDR o European Authorized Representative + MDV Medical Writing Services Menu Block o Clinical Evaluation o Performance Evaluation o Lifecycle Management o Literature Search Protocol and Review + MDV - Quality Management System services menu block o QMS Consultancy Services o ISO 14971 Risk Management Consulting o QMS Remediation o Compliance & Audit Support o QMS Toolkit o Document Management o Corrective and Preventive Action Management Services o Supplier Evaluation + MDV - new Artwork Services menu Block o Regulatory Artwork + MDV - Regulatory affairs services menu block o Device Documentation o Labeling Services o Technical Writing Services o RA Staff Augementation Services o Regulatory Consulting o Human Factors Engineering for Medical Devices o Market Intelligence Service o Medical and Scientific Communication o Mergers and Acquisitions Regulatory Services o Biocompatibility Services for Medical Devices + MDV - GRI Menu Blocks o Global Regulatory Intelligence Consumers Cosmetics Food Supplements Chemicals Spotlight + COS - Cosmetics services1 Menu o Cosmetic Product Labeling Review o Cosmetic Safety Assessment and Toxicology Services o Global Regulatory Compliance and Consulting (GRCC) o Formulation and Ingredient Review o Cosmetic Product Information File (PIF) o Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) o Go-to-market and Legal Representative (LR) o EUDR Compliance Services for Cosmetics Industry COS - Cosmetics services2 Menu o Comprehensive Artwork Services for Cosmetics o Global Cosmetovigilence Services o Claims Review o Cosmetic Testing o Cosmetic Regulatory Intelligence o Global Regulatory Intelligence + FDS - Service1 Menu block o Food & Food Supplements Product Services o Food and Food Supplements Artwork Services o Global Regulatory Compliance and Consulting (GRCC) o Novel Food Support (NDIN, GRAS, NSF) o Raw Material Specification Compliance o Ingredients/Formulation Compliance o Claims Review, Substantiation, and Notification Support o Food and Food Supplement Classification: A Global Overview o Manufacturing Facility Registration Support (FFR/FBO/Site license) o Labeling Compliance o Dossier Compilation Support o Food Product Registration Service/Notification o Legal Representation (LR) Support o Regulatory Audit and Training Support (GMPs, GHP, HACCP) o Food Regulatory Pathway Reports FDS Categories Supported menu block o Categories Supported o Cultured Food Products Regulatory Compliance for (Animal & Plant-Based) o Dietary Supplement Regulation and Compliance o Ensure Global Compliance for Your Tobacco and Nicotine Products o Herbal Supplements (Botanical Extracts) o Infant Formula Regulatory Compliance o Medical Foods / FSMP o Organic Foods o Probiotics, Prebiotics, Postbiotics & Synbiotics o Processed Food Products o Traditional Medicines Regulatory Compliance o Alcoholic Beverages FDS - Service2 Menu block o Sustainability Services o Recycling Logo Content and Design Support for Food and Food Supplements o Navigate EPR, PCR, PPWR & SUP Compliance with Confidence! o EU Deforestation Regulation Services o Ecolabelling Regulatory Support Global Regulatory Intelligence + CSRA - Chemicals service1 Menu o Chemical Data Scouting o Chemical Scientific Assessment Reports and Position Paper Report o Supply Chain Regulatory Compliance o Chemical Packaging Regulations o Global Biocidal Products Regulation Services o Regulation of Tobacco Products o Ecolabeling Regulatory Support o Chemical Safety Data Sheet (SDS) Authoring & Compliance Services o Household and Chemical Products Artwork Services o Sustainability Consulting Services CSRA - Chemicals service2 Menu o Extended Safety Data Sheet (eSDS) Services o Global Regulatory Compliance and Consulting (GRCC) o Pet Care Products Registration o General Product Safety Regulation (GPSR) o Global REACH Regulatory Compliance o Chemical Toxicological Risk Assessment o EUDR Compliance Services for Chemical & general consumer product o Environmental Risk Assessment (ERA) Services o Global Regulatory Intelligence + o EUDR Compliance | Food, Cosmetics & Chemicals o EUDR Knowledge Hub o Freya Fusion Stay Ahead with a Unified, AI-First Regulatory Cloud freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML. freya fusion is a unified ecosystem that empowers RIM and covers the entire regulatory lifecycle - from registrations and submissions to labeling, artwork, intelligence, and change control. Know More + Consumer + Medicinal products o Regulatory Affairs Services - Market Access with end-to-end Regulatory Solutions - Drug Development Regulatory Services * Pre-submission Meetings/HA Interactions * Clinical Trial Applications - Regulatory Strategy and Insights * Regulatory Strategy Consulting * Regulatory Submission Roadmaps/Regulatory Intelligence * Regulatory Staffing Services * Global Regulatory Affairs Services * Gap Analysis * Artificial Intelligence (AI)-powered Regulatory Services - Dossier Authoring * CTD Templates * Biologics Registration Services - Post Approval/Lifecycle Management * Post-Approval Change Submissions * Nitrosamine impurity Risk Assessment * Lifecycle Management - Country-specific Regulatory Services - Global Health Authorities-Specific Services * USFDA + Abbreviated New Drug Application Submissions + Biologics License Applications Submission + Drug Master File (DMF) Submissions + New Drug Application Submission + Investigational New Drug Applications + Nitrosamine Impurity Risk Assessment * Health Canada + Abbreviated New Drug Submission + New Drug Submission + Clinical Trial Application (CTA) Submissions + Drug Master File (DMF) Submissions * European + Active Substance Master File Submissions + Centralised Procedure + Certification of Suitability + Decentralized Procedure + EU Marketing Authorization Application + Investigational Medicinal Product Dossier + Mutual Recognition Procedure (MRP) + National Procedure (NP) - EU CTR Submissions o Regulatory Operations - Regulatory Publishing and Submissions * AI-powered Regulatory * Global eCTD Publishing and Submission Services * NeeS Submissions * Paper Submissions * CSR - Report-Level Publishing * Legacy Conversions * AD promo submission services * Archiving Services for Regulatory Publishing and Submission * Regulatory Data Migration Services * Regulatory Document Formatting Services * Submission QC Automation * Auto Document Level Publishing - Regulatory Labeling Services * Strategic Labeling Consulting + Process Consulting + Technology Consulting + Content Harmonization & Standardization + Go-to-market Labeling Strategies * Labeling Translation + Translation Creation & Updation + Translation Quality Check + Translation Coordination * Regional Labeling + USPI Preparation + EU Labeling + ROW Labeling + Linguistic Review + SPL/SPM (Creation & Updation) + Competitor Label Analysis + Label Comparison + Monitoring Reference Label Changes + Readability Test * Global Labeling + CCDS/CSI Creation & Updation + Monitoring CCDS Change implementation and Deviation Management + Local Justification Document Preparation * Clinical Labeling + Target Product Profiling (TPP) + Developmental CCDS Creation & Updation * Labeling Automation + Labeling Content Management + Labeling Templatization + Large-volume Change Automation + End-to-end Tracking + e-labeling * AI-powered Regulatory Labeling Services * Pharma Labeling Compliance o Regulatory Artwork Solutions - Regulatory Artwork Services * Artwork Graphic Studio + Packaging Artwork Mock-up Creation + Changes to Existing Artwork + Private Label Artwork for Pharma * Artwork Proofreading * Global Artwork Translation * Artwork Process Consultancy * Printed Packaging Print-Proof Quality Check * e-Leaflet and e-Label * Content to Carton * Artwork Lifecycle Coordination + End-to-End Artwork Workflow Coordination o Pharmacovigilance - Medical Literature Monitoring - Individual Case Safety Report - Aggregate Safety Reports - Pharmacovigilance Risk Management Plan - Pharmacovigilance (PV) Signal Detection Services - Pharmacovigilance (PV) Audit Services - Quality Control in Pharmacovigilance - Qualified Person for Pharmacovigilance - Regulatory Intelligence in Pharmacovigilance - Pharmacovigilance (PV) Safety Database Services & Solutions o Medical Writing - Clinical Services * Regulatory Writing Services * Clinical Trial and Consulting Services * Clinical Trial Audit and Monitoring Services * Quality Check and Medical Review of Regulatory Documents * Risk-Benefit Analysis * Clinical Data Transparency Initiative - Non-Clinical Writing Services - Regulatory Toxicology Services * ADE/PDE Determination/Report Services * F-Value Reports for Child Resistant Packaging (CRP) * Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables * Environmental Risk Assessment (ERA) of Medicinal Products - Clinical and Non-Clinical Consulting and Strategic Services * Clinical Writing Consulting and Strategic Services * Technical Writing Support for GxP Compliance * Business Process Optimization * Non-clinical Consulting & Strategic Services - Automation in Medical Writing * Narrative writing tool * Literature review tool * Quality review tool * End-to-End Medical Writing o Compliance and Audit Services - Pharma Quality and Compliance Services - SOP Writing and SOP Review Services - Pharma GxP Audit Services * Remote and Virtual Audits - Pharma CSV and CSA Services - QMS Remediation and Establishment Services - End-to-end Regulatory Compliance Services o Medical and Scientific Communication - Medical Copywriting Services - Medical and Scientific Writing Services - Manuscripts and Publications - Creative Scientific Design Studio - Promotional Materials MLR Review - Medical and Scientific Content Management - FDA Ad Promo Submission Services - OPDP 2253 o Global Regulatory Intelligence - Global Regulatory Intelligence o Generics - USFDA * Abbreviated New Drug Application * ANDA Refuse-to-Receive Practices * Due Diligence Assessment of ANDA * US FDA Health Authority Interactions * Pre-ANDA Submissions * Competitive Generic Therapies Designation * Product Development Strategy for Generic Drug * ANDA Post-approval Changes * Drug Master File (DMF) Submission * Change Control Assessment and Change Submission Strategy * ANDA Pre-Submission Facility Correspondence * Gap Analysis and Authoring * Publishing and Submission * US FDA Query Management (IRs/ DRLs/ CRLs) - EU- EMA * MAA Approval Support * MAA Registration * Health Authority Interactions in Europe * ASMF/CEP Submissions * Post-approval Changes to Drug Substance * MAH/QP/QPPV Requirements * Sunset Clause * Submission Slot Booking * Hybrid Applications * Renewals Submissions * Gap Analysis and Authoring * Publishing and Submission * Change Control Evaluation and Variation Submission Strategies - Health Canada * Regulatory Strategic Guidance * Health Canada ANDS * Health Canada Drug Master File (DMF) Submission * Change Control Evaluation and Submission Strategy * ANDA Post-approval Change Submissions * Canada Health Authority Interactions * Health Canada Query Management - Our Capabilities * Ensuring 'Right Opportunities' for 'Right Market' * Breaking complex generics Regulatory Challenges * Generic Application Expertise * Drug Master File (DMF) Submissions Expertise * First-to-File Generics * FAQs on Generics o Innovators - Our Regulatory Services * Biologics License Application (BLA) * Clinical Trial Applications (CTAs) * Investigational Medicinal Product Dossier * Investigational New Drug Applications * New Drug Applications * New Drug Submissions - Cross-functional specialty * Clinical Labeling * Clinical Trial Monitoring * DMF Capabilities * Toxicological Risk Assessment * Publishing and Submission Competencies * Regulatory Labeling Competencies * Regulatory Medical Writing Competencies * Regulatory Strategy Consulting Competencies * Artwork competencies - Regional Expertise * Regional Expertise - Freyr as a Partner from Discovery Stage * Freyr as a Partner from Discovery Stage + Medical Devices o Market Access - Device Registration Americas * USA + e-Star + 513(g) + 510(k) + Q-submission + Pre-market Approval + RFD & Pre-RFD + UDI and GUDID Solutions for the FDA Compliance * Canada + Canada ISED Representative Service + Medical Device Establishment Licence (MDEL) Solutions for Canada + Medical Device Importer Solutions for Compliance in Canada + Medical Device Licence (MDL) Solutions for Canada - Device Registration Europe * CE Marking * EU MDR * EU IVDR * European Authorized Representative - Device Registration China - Device Registration South Korea - Device Registration Australia - Device Registration UK - Device Registration Switzerland - Device Registration: Rest of the World - In-Country Representation * Australian TGA Sponsor * Korean Registration Holder (KRH) * Mexican Registration Holder (MRH) * US Agent * Swiss Authorised Representative (CH-Rep) * UK Responsible Person (UKRP) * Designated Market Authorization Holder (DMAH) * China Agent Services * Brazil Registration Holder (BRH) * Indian Authorization Agent for Medical Device Registration in India * In-country representation Rest of the world o Post Market Surveillance - Product Complaints Management - Device Recall, Corrections and Removals - PMSP, PMSR, PMCF, PSUR, Annual Maintenance * Post-Market Surveillance (PMS) * Periodic Safety Update Report (PSUR) - Health Hazard Evaluation - Medical Device Translation Services o Medical Writing for Medical Devices - Clinical Evaluation * Clinical Evaluation Plan (CEP) * Clinical evaluation report (CER) - Performance Evaluation * Scientific Validity Report (SVR) * Clinical Performance Report (CPR) * Analytical Performance Report (APR) * Performance Evaluation for In Vitro Diagnostic Medical Devices * Performance EvaluationReport (PER) IVDR - Lifecycle Management - Literature Search Protocol and Review o Regulatory Affairs - Device Documentation * Device History File * Device Technical File Publishing - Labeling Services - Technical Writing Services - RA Staff Augementation Services - Regulatory Consulting * Life cycle management * Medical Device Consulting * IVD Consulting * SaMD Consulting * Combination product Consulting * Regulatory Intelligence * Device classification & Categorization - Human Factors Engineering for Medical Devices - Market Intelligence Service - Medical and Scientific Communication - Mergers and Acquisitions Regulatory Services - Biocompatibility Services for Medical Devices o Quality, Compliance, and Audit - QMS Consultancy Services - ISO 14971 Risk Management Consulting - QMS Remediation - Compliance & Audit Support - QMS Toolkit - Document Management - Corrective and Preventive Action Management Services - Supplier Evaluation o Digital Health/SaMD - SaMD Registration in the US - SaMD Registration in the EU - Global Market Expansion for SaMD - Regulatory Strategy Consultation for SaMD - Quality Management Systems Implementation o Artwork Services - Regulatory Artwork o Global Regulatory Intelligence - Global Regulatory Intelligence + Cosmetics o Cosmetics Services - Cosmetic Product Labeling Review - Cosmetic Safety Assessment and Toxicology Services - Global Regulatory Compliance and Consulting (GRCC) - Formulation and Ingredient Review - Cosmetic Product Information File (PIF) - Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) - Go-to-market and Legal Representative (LR) - EUDR Compliance Services for Cosmetics Industry o Cosmetics Service - Comprehensive Artwork Services for Cosmetics - Global Cosmetovigilence Services - Claims Review - Cosmetic Testing - Cosmetic Regulatory Intelligence - Global Regulatory Intelligence + Food Supplements o Food & Food Supplements Product Services - Food & Food Supplements Product Services - Food and Food Supplements Artwork Services - Global Regulatory Compliance and Consulting (GRCC) - Novel Food Support (NDIN, GRAS, NSF) - Raw Material Specification Compliance - Ingredients/Formulation Compliance - Claims Review, Substantiation, and Notification Support - Food and Food Supplement Classification: A Global Overview - Manufacturing Facility Registration Support (FFR/FBO/Site license) - Labeling Compliance - Dossier Compilation Support - Food Product Registration Service/Notification - Legal Representation (LR) Support - Regulatory Audit and Training Support (GMPs, GHP, HACCP) - Food Regulatory Pathway Reports o Sustainability Services - Sustainability Services - Recycling Logo Content and Design Support for Food and Food Supplements - Navigate EPR, PCR, PPWR & SUP Compliance with Confidence! - EU Deforestation Regulation Services - Ecolabelling Regulatory Support o Categories Supported - Categories Supported - Cultured Food Products Regulatory Compliance for (Animal & Plant-Based) - Dietary Supplement Regulation and Compliance - Ensure Global Compliance for Your Tobacco and Nicotine Products - Herbal Supplements (Botanical Extracts) - Infant Formula Regulatory Compliance - Medical Foods / FSMP - Organic Foods - Probiotics, Prebiotics, Postbiotics & Synbiotics - Processed Food Products - Traditional Medicines Regulatory Compliance - Alcoholic Beverages + Chemicals o CSRA Services - Chemical Data Scouting - Chemical Scientific Assessment Reports and Position Paper Report - Supply Chain Regulatory Compliance - Chemical Packaging Regulations - Global Biocidal Products Regulation Services - Regulation of Tobacco Products - Ecolabeling Regulatory Support - Chemical Safety Data Sheet (SDS) Authoring & Compliance Services - Household and Chemical Products Artwork Services - Sustainability Consulting Services o CSRA Services - Extended Safety Data Sheet (eSDS) Services - Global Regulatory Compliance and Consulting (GRCC) - Pet Care Products Registration - General Product Safety Regulation (GPSR) - Global REACH Regulatory Compliance - Chemical Toxicological Risk Assessment - EUDR Compliance Services for Chemical & general consumer product - Environmental Risk Assessment (ERA) Services - Global Regulatory Intelligence * Global Toggle submenu Americas Europe Asia-Pacific Africa & Middle East Global Americas Menu Block + Argentina + Bolivia + Brazil + Canada + Chile + Colombia + Costa Rica + Dominican Republic + Guatemala + Mexico + Panama + Paraguay + Peru + Puerto Rico + United States + Venezuela Global Europe Menu Block + Albania + Austria + Belarus + Belgium + Bulgaria + Croatia + Cyprus + Czech Republic + Denmark + Estonia + European Union + Finland + France + Germany + Greece + Hungary + Ireland + Italy + Kazakhstan + Kosovo + Latvia + Lithuania + Luxembourg + Macedonia + Malta + Netherlands + Norway + Poland + Portugal + Romania + Serbia + Slovakia + Slovenia + Spain + Sweden + Switzerland + United Kingdom + Uzbekistan Global Asia - Pacific Menu Block + Australia + Bangladesh + Cambodia + China + Hong Kong + India + Indonesia + Japan + Malaysia + New Zealand + Pakistan + Philippines + Singapore + South Korea + Sri Lanka + Taiwan + Thailand + Vietnam Global Africa & Middle East Menu Block + Algeria + Bahrain + Egypt + Ethiopia + Ghana + Iraq + Israel + Jordan + Kenya + Kuwait + Lebanon + Morocco + Nigeria + Qatar + Saudi Arabia + South Africa + Tunisia + Turkey + UAE + Uganda + Yemen + Zimbabwe + Americas o Argentina o Bolivia o Brazil o Canada o Chile o Colombia o Costa Rica o Dominican Republic o Guatemala o Mexico o Panama o Paraguay o Peru o Puerto Rico o United States o Venezuela + Europe o Albania o Austria o Belarus o Belgium o Bulgaria o Croatia o Cyprus o Czech Republic o Denmark o Estonia o Finland o France o Germany o European Union o Greece o Hungary o Ireland o Italy o Kazakhstan o Kosovo o Latvia o Lithuania o Luxembourg o Macedonia o Malta o Netherlands o Norway o Poland o Portugal o Romania o Serbia o Slovakia o Slovenia o Spain o Sweden o Switzerland o United Kingdom o Uzbekistan + Asia-Pacific o Australia o Bangladesh o Cambodia o China o Hong Kong o India o Indonesia o Japan o Malaysia o New Zealand o Pakistan o Philippines o Singapore o South Korea o Sri Lanka o Taiwan o Thailand o Vietnam + Africa & Middle East o Algeria o Bahrain o Egypt o Ethiopia o Ghana o Iraq o Israel o Jordan o Kenya o Lebanon o Morocco o Kuwait o Nigeria o Qatar o Saudi Arabia o South Africa o Tunisia o Turkey o UAE o Uganda o Yemen o Zimbabwe * Customers Toggle submenu + Success Stories + Case Studies + Testimonials * Insights Toggle submenu + Blogs + Brochures + Infographics + Webinars + Freyr Podcasts + What is ...? + White Papers + Fireside Chats + e-Books + Global Health Authority Mandates + Regulatory Roundup + Templates and Checklists + Industry News + Videos + Toolkits * Company Toggle submenu + About Us + Awards & Recognitions + Press Releases + Freyr in Media + Industry Events + Freyr Events + Careers + Compliance Wall + Corporate Social Responsibility + Functional Delivery Models + Partner with Us + Contact Us * Get in Touch * English + Japan (Japanese | English) + South Korea (Korean | English) + China (Chinese | English) + Mexico (Español | English) + Brazil (Portuguese | English) + Australia (English) + Sri Lanka (English) + India (English) + Malaysia (English) + Nigeria (English) + Saudi Arabia (English) + Thailand (English) * * + +1 908 483 7958 + +44 2037 012379 + +1 778 308 4671 + +49 6181 707 9007 + +52 55 41613365 + +65 315 894 72 + +62 604 2250544 + +91 40 4848 0999 + +61 2 8607 5105 + +41 225 087 129 * + sales@freyrsolutions.com + hr@freyrsolutions.com Breadcrumb 1. Home 2. Insights 3. Freyr Blogs Freyr Blogs Featured Blogs 2 min read January 2, 2026 Food Supplements EUDR 2025 Agreement: Deadlines Extended, Obligations Clarified, Scope Refined 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs Japan Implements ICH Guidelines for Generic Pharmaceuticals: What Global Manufacturers Must Prepare for by April 2026 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs India’s Transition Toward Mandatory eCTD Submissions: What Pharma Manufacturers Must Prepare for in 2026 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs Accelerating Market Entry in Australia: How Enhanced TGA Regulatory Pathways Support Faster Pharmaceutical Approvals 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs The Farmatag® Safety Label Malaysia Update - What’s Changing and Why It Matters to You PreviousNext * All * Medicinal Products * Medical Devices * Cosmetics * Food Supplements * Chemicals * Freyr Digital * 3 min read January 5, 2026 Medicinal Products, Publishing and Submission How to Build a Submission-Ready Dossier: Freyr’s 2026 Compliance Framework * 3 min read January 5, 2026 Medicinal Products, Publishing and Submission Japan PMDA eCTD Best Practices for 2026 Submissions: A Practical, Submission-Ready Guide for Regulatory Teams * 2 min read January 2, 2026 Food Supplements EUDR 2025 Agreement: Deadlines Extended, Obligations Clarified, Scope Refined * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs OTC Registration Malaysia: 8 Key Things to Know * 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs Japan Implements ICH Guidelines for Generic Pharmaceuticals: What Global Manufacturers Must Prepare for by April 2026 * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs India’s Transition Toward Mandatory eCTD Submissions: What Pharma Manufacturers Must Prepare for in 2026 * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs Accelerating Market Entry in Australia: How Enhanced TGA Regulatory Pathways Support Faster Pharmaceutical Approvals * 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs The Farmatag® Safety Label Malaysia Update - What’s Changing and Why It Matters to You * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs 11 Must-Know FAQs: Pharmaceutical Product Approval in Nigeria * 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs 6 Challenges in Regulatory Affairs in Pharmaceutical Industry in Philippines & solutions * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs Pharmaceutical Industry in the Philippines: An Emerging Hub for Growth * 1 min read December 10, 2025 Medicinal Products, Regulatory Affairs What Is the Medicinal Product Regulatory Framework in South Africa? A Step-by-Step Guide for Regulatory Affairs Pagination * View More Blogs How can we help you? Please let us know your requirements, and we will contact you. You must have JavaScript enabled to use this form. Select IndustryMedicinal Products Medical DevicesCosmeticsFood SupplementsChemicals I have read the privacy policy Submitted Page URL Website URL Content Type Form Name Leave this field blank * Americas * Europe * Asia-Pacific * Africa & Middle East +1 908 483 7958 +44 203 701 2379 +91 40 4848 0999 +27 105 002 556 sales@freyrsolutions.com Connect with Us * * * * * Terms of Use | Privacy Policy | Cookie Policy © Copyright 2025 Freyr. All Rights Reserved. | Skip to main content Contact Us × You must have JavaScript enabled to use this form. Full Name Business Email Contact Number Message How did you hear about us? - Select -Search EngineE-mail CampaignGoogle AdsSocial MediaLink from another websiteColleague’s RecommendationNewsletterPrinted BrochureOther Other (Please specify) I have read the privacy policy Submitted Page URL Website URL Content Type Form Name Leave this field blank What are you looking for? × Search Get in Touch × You must have JavaScript enabled to use this form. Name Company Business Email Contact Number Message How did you hear about us? - Select -Search EngineE-mail CampaignGoogle AdsSocial MediaLink from another websiteColleague’s RecommendationNewsletterPrinted BrochureOther Other (Please specify) I have read the privacy policy Submitted Page URL Content Type Website URL Form Name Leave this field blank Consult × * Test Drive , our AI Chatbot - get instant regulatory answers, free and live! * Try Now . * Get in Touch * * * * * Home * Solutions + Back + Solutions + Medicinal Products o Back o Medicinal Products Regulatory Services Regulatory Affairs Regulatory Operations Regulatory Medical Writing Regulatory Pharmacovigilance Medical and Scientific Communication Compliance, Audit, and Validation Regulatory Artwork Solutions Global Regulatory Intelligence - MPR - Regulatory Affairs Menu Block * Market Access with end-to-end Regulatory Solutions * Drug Development Regulatory Services * Regulatory Strategy and Insights * Dossier Authoring * Post Approval/Lifecycle Management * Country-specific Regulatory Services * Global Health Authorities-Specific Services * EU CTR Submissions - MPR - Regulatory Operations Menu * Regulatory Publishing and Submissions * Regulatory Labeling Services - MPR - Medical Writing Menu Block * Clinical Services * Non-Clinical Writing Services * Regulatory Toxicology Services * Clinical and Non-Clinical Consulting and Strategic Services * Automation in Medical Writing - MPR - Pharmacovigilance Menu Block * Medical Literature Monitoring * Individual Case Safety Report * Aggregate Safety Reports * Pharmacovigilance Risk Management Plan * Pharmacovigilance (PV) Signal Detection Services * Pharmacovigilance (PV) Audit Services * Quality Control in Pharmacovigilance * Qualified Person for Pharmacovigilance * Regulatory Intelligence in Pharmacovigilance * Pharmacovigilance (PV) Safety Database Services & Solutions - MPR - Medical & Scientific Communication Menu Block * Medical Copywriting Services * Medical and Scientific Writing Services * Manuscripts and Publications * Creative Scientific Design Studio * Promotional Materials MLR Review * Medical and Scientific Content Management * FDA Ad Promo Submission Services - OPDP 2253 - MPR - Compliance and Audit Services Menu Block * Pharma Quality and Compliance Services * SOP Writing and SOP Review Services * Pharma GxP Audit Services * Pharma CSV and CSA Services * QMS Remediation and Establishment Services * End-to-end Regulatory Compliance Services - MPR - New Regulatory Artwork Solutions Menu Block * Regulatory Artwork Services MPR - Artwork Menu Block * Artwork Graphic Studio * Artwork Proofreading * Global Artwork Translation * Artwork Process Consultancy * Printed Packaging Print-Proof Quality Check * e-Leaflet and e-Label * Content to Carton * Artwork Lifecycle Coordination - MPR - GRI Menu Blocks * Global Regulatory Intelligence + Medical Devices o Back o Medical Devices Regulatory Services Digital Health / SaMD Market Access Post Market Surveillance EU Compliance Clinical & Performance Evaluation Quality, Compliance, & Audit Artwork Services Regulatory Affairs Global Regulatory Intelligence - MDV - Digital Health/SaMD services menu block * SaMD Registration in the US * SaMD Registration in the EU * Global Market Expansion for SaMD * Regulatory Strategy Consultation for SaMD * Quality Management Systems Implementation - MDV - Market Access menu block * Device Registration Americas * Device Registration Europe * Device Registration China * Device Registration South Korea * Device Registration Australia * Device Registration UK * Device Registration Switzerland * Device Registration: Rest of the World * In-Country Representation - MDV - Post Market Surveillance Menu Block * Product Complaints Management * Device Recall, Corrections and Removals * PMSP, PMSR, PMCF, PSUR, Annual Maintenance * Health Hazard Evaluation * Medical Device Translation Services - EU Compliance MDV menu Block * CE Marking * EU MDR * EU IVDR * European Authorized Representative - MDV Medical Writing Services Menu Block * Clinical Evaluation * Performance Evaluation * Lifecycle Management * Literature Search Protocol and Review - MDV - Quality Management System services menu block * QMS Consultancy Services * ISO 14971 Risk Management Consulting * QMS Remediation * Compliance & Audit Support * QMS Toolkit * Document Management * Corrective and Preventive Action Management Services * Supplier Evaluation - MDV - new Artwork Services menu Block * Regulatory Artwork - MDV - Regulatory affairs services menu block * Device Documentation * Labeling Services * Technical Writing Services * RA Staff Augementation Services * Regulatory Consulting * Human Factors Engineering for Medical Devices * Market Intelligence Service * Medical and Scientific Communication * Mergers and Acquisitions Regulatory Services * Biocompatibility Services for Medical Devices - MDV - GRI Menu Blocks * Global Regulatory Intelligence + Cosmetics o Back o Cosmetics Regulatory Services COS - Cosmetics services1 Menu - Cosmetic Product Labeling Review - Cosmetic Safety Assessment and Toxicology Services - Global Regulatory Compliance and Consulting (GRCC) - Formulation and Ingredient Review - Cosmetic Product Information File (PIF) - Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) - Go-to-market and Legal Representative (LR) - EUDR Compliance Services for Cosmetics Industry COS - Cosmetics services2 Menu - Comprehensive Artwork Services for Cosmetics - Global Cosmetovigilence Services - Claims Review - Cosmetic Testing - Cosmetic Regulatory Intelligence - Global Regulatory Intelligence + Food Supplements o Back o Food Supplements Regulatory Services Food Product Service FDS - Food Product Service menu - Food & Food Supplements Product Services - Food and Food Supplements Artwork Services - Global Regulatory Compliance and Consulting (GRCC) - Novel Food Support (NDIN, GRAS, NSF) - Raw Material Specification Compliance - Ingredients/Formulation Compliance - Claims Review, Substantiation, and Notification Support - Food and Food Supplement Classification: A Global Overview - Manufacturing Facility Registration Support (FFR/FBO/Site license) - Labeling Compliance - Dossier Compilation Support - Food Product Registration Service/Notification - Legal Representation (LR) Support - Regulatory Audit and Training Support (GMPs, GHP, HACCP) - Food Regulatory Pathway Reports Food Product Compliance FDS - Food Product Compliance Menu - Sustainability Services - Recycling Logo Content and Design Support for Food and Food Supplements - Navigate EPR, PCR, PPWR & SUP Compliance with Confidence! - EU Deforestation Regulation Services - Ecolabelling Regulatory Support Novel Food Registration + Chemicals o Back o Chemicals Regulatory Services CSRA - Chemicals service1 Menu - Chemical Data Scouting - Chemical Scientific Assessment Reports and Position Paper Report - Supply Chain Regulatory Compliance - Chemical Packaging Regulations - Global Biocidal Products Regulation Services - Regulation of Tobacco Products - Ecolabeling Regulatory Support - Chemical Safety Data Sheet (SDS) Authoring & Compliance Services - Household and Chemical Products Artwork Services - Sustainability Consulting Services CSRA - Chemicals service2 Menu - Extended Safety Data Sheet (eSDS) Services - Global Regulatory Compliance and Consulting (GRCC) - Pet Care Products Registration - General Product Safety Regulation (GPSR) - Global REACH Regulatory Compliance - Chemical Toxicological Risk Assessment - EUDR Compliance Services for Chemical & general consumer product - Environmental Risk Assessment (ERA) Services - Global Regulatory Intelligence + Spotlight o Back o Spotlight - EUDR Compliance | Food, Cosmetics & Chemicals - EUDR Knowledge Hub * Global + Back + Global + Americas o Back o Americas o Mobile Menu Americas - Argentina - Bolivia - Brazil - Canada - Chile - Colombia - Costa Rica - Dominican Republic - Guatemala - Mexico - Panama - Paraguay - Peru - Puerto Rico - United States - Venezuela + Europe o Back o Europe o Mobile Menu Eupope - Albania - Austria - Belarus - Belgium - Bulgaria - Croatia - Cyprus - Czech Republic - Denmark - Estonia - European Union - Finland - France - Germany - Greece - Hungary - Ireland - Italy - Kazakhstan - Kosovo - Latvia - Lithuania - Luxembourg - Macedonia - Malta - Netherlands - Norway - Poland - Portugal - Romania - Serbia - Slovakia - Slovenia - Spain - Sweden - Switzerland - United Kingdom - Uzbekistan + Asia - Pacific o Back o Asia - Pacific o Mobile Menu Asia - Pacific - Australia - Bangladesh - Cambodia - China - Hong Kong - India - Indonesia - Japan - Malaysia - New Zealand - Pakistan - Philippines - Singapore - South Korea - Sri Lanka - Taiwan - Thailand - Vietnam + Africa & Middle East o Back o Africa & Middle East o Mobile Menu Africa & Middle East - Algeria - Bahrain - Egypt - Ethiopia - Ghana - Iraq - Israel - Jordan - Kenya - Kuwait - Lebanon - Morocco - Nigeria - Qatar - Saudi Arabia - South Africa - Tunisia - Turkey - UAE - Uganda - Yemen - Zimbabwe * Customers + Back + Customers + Mobile Menu Customers o Success Stories o Case Studies o Testimonials * Insights + Back + Insights + Mobile Menu Insights o Blogs o Brochures o Infographics o Webinars o Freyr Podcasts o What is ...? o White Papers o Fireside Chats o e-Books o Global Health Authority Mandates o Regulatory Roundup o Templates and Checklists o Industry News o Videos o Toolkits * Company + Back + Company + Mobile Menu Company o About Us o Awards & Recognitions o Press Releases o Freyr in Media o Industry Events o Freyr Events o Careers o Compliance Wall o Corporate Social Responsibility o Functional Delivery Models o Partner with Us o Contact Us * Select Country + Japan Japanese | English + South Korea Korean | English + China Chinese | English + Mexico Español | English + Brazil Portuguese | English + Australia English + Sri Lanka English + India English + Malaysia English + Nigeria English + Saudi Arabia English + Thailand English * Solutions Toggle submenu Medicinal Products Medical Devices Consumer freya fusion Medicinal Products Regulatory Services Regulatory Affairs Regulatory Operations Regulatory Medical Writing Regulatory Pharmacovigilance Medical and Scientific Communication Compliance, Audit, and Validation Regulatory Artwork Solutions Global Regulatory Intelligence + MPR - Regulatory Affairs Menu Block o Market Access with end-to-end Regulatory Solutions o Drug Development Regulatory Services o Regulatory Strategy and Insights o Dossier Authoring o Post Approval/Lifecycle Management o Country-specific Regulatory Services o Global Health Authorities-Specific Services o EU CTR Submissions + MPR - Regulatory Operations Menu o Regulatory Publishing and Submissions o Regulatory Labeling Services + MPR - Medical Writing Menu Block o Clinical Services o Non-Clinical Writing Services o Regulatory Toxicology Services o Clinical and Non-Clinical Consulting and Strategic Services o Automation in Medical Writing + MPR - Pharmacovigilance Menu Block o Medical Literature Monitoring o Individual Case Safety Report o Aggregate Safety Reports o Pharmacovigilance Risk Management Plan o Pharmacovigilance (PV) Signal Detection Services o Pharmacovigilance (PV) Audit Services o Quality Control in Pharmacovigilance o Qualified Person for Pharmacovigilance o Regulatory Intelligence in Pharmacovigilance o Pharmacovigilance (PV) Safety Database Services & Solutions + MPR - Medical & Scientific Communication Menu Block o Medical Copywriting Services o Medical and Scientific Writing Services o Manuscripts and Publications o Creative Scientific Design Studio o Promotional Materials MLR Review o Medical and Scientific Content Management o FDA Ad Promo Submission Services - OPDP 2253 + MPR - Compliance and Audit Services Menu Block o Pharma Quality and Compliance Services o SOP Writing and SOP Review Services o Pharma GxP Audit Services o Pharma CSV and CSA Services o QMS Remediation and Establishment Services o End-to-end Regulatory Compliance Services + MPR - New Regulatory Artwork Solutions Menu Block o Regulatory Artwork Services MPR - Artwork Menu Block o Artwork Graphic Studio o Artwork Proofreading o Global Artwork Translation o Artwork Process Consultancy o Printed Packaging Print-Proof Quality Check o e-Leaflet and e-Label o Content to Carton o Artwork Lifecycle Coordination + MPR - GRI Menu Blocks o Global Regulatory Intelligence Medical Devices Regulatory Services Digital Health / SaMD Market Access Post Market Surveillance EU Compliance Clinical & Performance Evaluation Quality, Compliance, & Audit Artwork Services Regulatory Affairs Global Regulatory Intelligence + MDV - Digital Health/SaMD services menu block o SaMD Registration in the US o SaMD Registration in the EU o Global Market Expansion for SaMD o Regulatory Strategy Consultation for SaMD o Quality Management Systems Implementation + MDV - Market Access menu block o Device Registration Americas o Device Registration Europe o Device Registration China o Device Registration South Korea o Device Registration Australia o Device Registration UK o Device Registration Switzerland o Device Registration: Rest of the World o In-Country Representation + MDV - Post Market Surveillance Menu Block o Product Complaints Management o Device Recall, Corrections and Removals o PMSP, PMSR, PMCF, PSUR, Annual Maintenance o Health Hazard Evaluation o Medical Device Translation Services + EU Compliance MDV menu Block o CE Marking o EU MDR o EU IVDR o European Authorized Representative + MDV Medical Writing Services Menu Block o Clinical Evaluation o Performance Evaluation o Lifecycle Management o Literature Search Protocol and Review + MDV - Quality Management System services menu block o QMS Consultancy Services o ISO 14971 Risk Management Consulting o QMS Remediation o Compliance & Audit Support o QMS Toolkit o Document Management o Corrective and Preventive Action Management Services o Supplier Evaluation + MDV - new Artwork Services menu Block o Regulatory Artwork + MDV - Regulatory affairs services menu block o Device Documentation o Labeling Services o Technical Writing Services o RA Staff Augementation Services o Regulatory Consulting o Human Factors Engineering for Medical Devices o Market Intelligence Service o Medical and Scientific Communication o Mergers and Acquisitions Regulatory Services o Biocompatibility Services for Medical Devices + MDV - GRI Menu Blocks o Global Regulatory Intelligence Consumers Cosmetics Food Supplements Chemicals Spotlight + COS - Cosmetics services1 Menu o Cosmetic Product Labeling Review o Cosmetic Safety Assessment and Toxicology Services o Global Regulatory Compliance and Consulting (GRCC) o Formulation and Ingredient Review o Cosmetic Product Information File (PIF) o Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) o Go-to-market and Legal Representative (LR) o EUDR Compliance Services for Cosmetics Industry COS - Cosmetics services2 Menu o Comprehensive Artwork Services for Cosmetics o Global Cosmetovigilence Services o Claims Review o Cosmetic Testing o Cosmetic Regulatory Intelligence o Global Regulatory Intelligence + FDS - Service1 Menu block o Food & Food Supplements Product Services o Food and Food Supplements Artwork Services o Global Regulatory Compliance and Consulting (GRCC) o Novel Food Support (NDIN, GRAS, NSF) o Raw Material Specification Compliance o Ingredients/Formulation Compliance o Claims Review, Substantiation, and Notification Support o Food and Food Supplement Classification: A Global Overview o Manufacturing Facility Registration Support (FFR/FBO/Site license) o Labeling Compliance o Dossier Compilation Support o Food Product Registration Service/Notification o Legal Representation (LR) Support o Regulatory Audit and Training Support (GMPs, GHP, HACCP) o Food Regulatory Pathway Reports FDS Categories Supported menu block o Categories Supported o Cultured Food Products Regulatory Compliance for (Animal & Plant-Based) o Dietary Supplement Regulation and Compliance o Ensure Global Compliance for Your Tobacco and Nicotine Products o Herbal Supplements (Botanical Extracts) o Infant Formula Regulatory Compliance o Medical Foods / FSMP o Organic Foods o Probiotics, Prebiotics, Postbiotics & Synbiotics o Processed Food Products o Traditional Medicines Regulatory Compliance o Alcoholic Beverages FDS - Service2 Menu block o Sustainability Services o Recycling Logo Content and Design Support for Food and Food Supplements o Navigate EPR, PCR, PPWR & SUP Compliance with Confidence! o EU Deforestation Regulation Services o Ecolabelling Regulatory Support Global Regulatory Intelligence + CSRA - Chemicals service1 Menu o Chemical Data Scouting o Chemical Scientific Assessment Reports and Position Paper Report o Supply Chain Regulatory Compliance o Chemical Packaging Regulations o Global Biocidal Products Regulation Services o Regulation of Tobacco Products o Ecolabeling Regulatory Support o Chemical Safety Data Sheet (SDS) Authoring & Compliance Services o Household and Chemical Products Artwork Services o Sustainability Consulting Services CSRA - Chemicals service2 Menu o Extended Safety Data Sheet (eSDS) Services o Global Regulatory Compliance and Consulting (GRCC) o Pet Care Products Registration o General Product Safety Regulation (GPSR) o Global REACH Regulatory Compliance o Chemical Toxicological Risk Assessment o EUDR Compliance Services for Chemical & general consumer product o Environmental Risk Assessment (ERA) Services o Global Regulatory Intelligence + o EUDR Compliance | Food, Cosmetics & Chemicals o EUDR Knowledge Hub o Freya Fusion Stay Ahead with a Unified, AI-First Regulatory Cloud freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML. freya fusion is a unified ecosystem that empowers RIM and covers the entire regulatory lifecycle - from registrations and submissions to labeling, artwork, intelligence, and change control. Know More + Consumer + Medicinal products o Regulatory Affairs Services - Market Access with end-to-end Regulatory Solutions - Drug Development Regulatory Services * Pre-submission Meetings/HA Interactions * Clinical Trial Applications - Regulatory Strategy and Insights * Regulatory Strategy Consulting * Regulatory Submission Roadmaps/Regulatory Intelligence * Regulatory Staffing Services * Global Regulatory Affairs Services * Gap Analysis * Artificial Intelligence (AI)-powered Regulatory Services - Dossier Authoring * CTD Templates * Biologics Registration Services - Post Approval/Lifecycle Management * Post-Approval Change Submissions * Nitrosamine impurity Risk Assessment * Lifecycle Management - Country-specific Regulatory Services - Global Health Authorities-Specific Services * USFDA + Abbreviated New Drug Application Submissions + Biologics License Applications Submission + Drug Master File (DMF) Submissions + New Drug Application Submission + Investigational New Drug Applications + Nitrosamine Impurity Risk Assessment * Health Canada + Abbreviated New Drug Submission + New Drug Submission + Clinical Trial Application (CTA) Submissions + Drug Master File (DMF) Submissions * European + Active Substance Master File Submissions + Centralised Procedure + Certification of Suitability + Decentralized Procedure + EU Marketing Authorization Application + Investigational Medicinal Product Dossier + Mutual Recognition Procedure (MRP) + National Procedure (NP) - EU CTR Submissions o Regulatory Operations - Regulatory Publishing and Submissions * AI-powered Regulatory * Global eCTD Publishing and Submission Services * NeeS Submissions * Paper Submissions * CSR - Report-Level Publishing * Legacy Conversions * AD promo submission services * Archiving Services for Regulatory Publishing and Submission * Regulatory Data Migration Services * Regulatory Document Formatting Services * Submission QC Automation * Auto Document Level Publishing - Regulatory Labeling Services * Strategic Labeling Consulting + Process Consulting + Technology Consulting + Content Harmonization & Standardization + Go-to-market Labeling Strategies * Labeling Translation + Translation Creation & Updation + Translation Quality Check + Translation Coordination * Regional Labeling + USPI Preparation + EU Labeling + ROW Labeling + Linguistic Review + SPL/SPM (Creation & Updation) + Competitor Label Analysis + Label Comparison + Monitoring Reference Label Changes + Readability Test * Global Labeling + CCDS/CSI Creation & Updation + Monitoring CCDS Change implementation and Deviation Management + Local Justification Document Preparation * Clinical Labeling + Target Product Profiling (TPP) + Developmental CCDS Creation & Updation * Labeling Automation + Labeling Content Management + Labeling Templatization + Large-volume Change Automation + End-to-end Tracking + e-labeling * AI-powered Regulatory Labeling Services * Pharma Labeling Compliance o Regulatory Artwork Solutions - Regulatory Artwork Services * Artwork Graphic Studio + Packaging Artwork Mock-up Creation + Changes to Existing Artwork + Private Label Artwork for Pharma * Artwork Proofreading * Global Artwork Translation * Artwork Process Consultancy * Printed Packaging Print-Proof Quality Check * e-Leaflet and e-Label * Content to Carton * Artwork Lifecycle Coordination + End-to-End Artwork Workflow Coordination o Pharmacovigilance - Medical Literature Monitoring - Individual Case Safety Report - Aggregate Safety Reports - Pharmacovigilance Risk Management Plan - Pharmacovigilance (PV) Signal Detection Services - Pharmacovigilance (PV) Audit Services - Quality Control in Pharmacovigilance - Qualified Person for Pharmacovigilance - Regulatory Intelligence in Pharmacovigilance - Pharmacovigilance (PV) Safety Database Services & Solutions o Medical Writing - Clinical Services * Regulatory Writing Services * Clinical Trial and Consulting Services * Clinical Trial Audit and Monitoring Services * Quality Check and Medical Review of Regulatory Documents * Risk-Benefit Analysis * Clinical Data Transparency Initiative - Non-Clinical Writing Services - Regulatory Toxicology Services * ADE/PDE Determination/Report Services * F-Value Reports for Child Resistant Packaging (CRP) * Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables * Environmental Risk Assessment (ERA) of Medicinal Products - Clinical and Non-Clinical Consulting and Strategic Services * Clinical Writing Consulting and Strategic Services * Technical Writing Support for GxP Compliance * Business Process Optimization * Non-clinical Consulting & Strategic Services - Automation in Medical Writing * Narrative writing tool * Literature review tool * Quality review tool * End-to-End Medical Writing o Compliance and Audit Services - Pharma Quality and Compliance Services - SOP Writing and SOP Review Services - Pharma GxP Audit Services * Remote and Virtual Audits - Pharma CSV and CSA Services - QMS Remediation and Establishment Services - End-to-end Regulatory Compliance Services o Medical and Scientific Communication - Medical Copywriting Services - Medical and Scientific Writing Services - Manuscripts and Publications - Creative Scientific Design Studio - Promotional Materials MLR Review - Medical and Scientific Content Management - FDA Ad Promo Submission Services - OPDP 2253 o Global Regulatory Intelligence - Global Regulatory Intelligence o Generics - USFDA * Abbreviated New Drug Application * ANDA Refuse-to-Receive Practices * Due Diligence Assessment of ANDA * US FDA Health Authority Interactions * Pre-ANDA Submissions * Competitive Generic Therapies Designation * Product Development Strategy for Generic Drug * ANDA Post-approval Changes * Drug Master File (DMF) Submission * Change Control Assessment and Change Submission Strategy * ANDA Pre-Submission Facility Correspondence * Gap Analysis and Authoring * Publishing and Submission * US FDA Query Management (IRs/ DRLs/ CRLs) - EU- EMA * MAA Approval Support * MAA Registration * Health Authority Interactions in Europe * ASMF/CEP Submissions * Post-approval Changes to Drug Substance * MAH/QP/QPPV Requirements * Sunset Clause * Submission Slot Booking * Hybrid Applications * Renewals Submissions * Gap Analysis and Authoring * Publishing and Submission * Change Control Evaluation and Variation Submission Strategies - Health Canada * Regulatory Strategic Guidance * Health Canada ANDS * Health Canada Drug Master File (DMF) Submission * Change Control Evaluation and Submission Strategy * ANDA Post-approval Change Submissions * Canada Health Authority Interactions * Health Canada Query Management - Our Capabilities * Ensuring 'Right Opportunities' for 'Right Market' * Breaking complex generics Regulatory Challenges * Generic Application Expertise * Drug Master File (DMF) Submissions Expertise * First-to-File Generics * FAQs on Generics o Innovators - Our Regulatory Services * Biologics License Application (BLA) * Clinical Trial Applications (CTAs) * Investigational Medicinal Product Dossier * Investigational New Drug Applications * New Drug Applications * New Drug Submissions - Cross-functional specialty * Clinical Labeling * Clinical Trial Monitoring * DMF Capabilities * Toxicological Risk Assessment * Publishing and Submission Competencies * Regulatory Labeling Competencies * Regulatory Medical Writing Competencies * Regulatory Strategy Consulting Competencies * Artwork competencies - Regional Expertise * Regional Expertise - Freyr as a Partner from Discovery Stage * Freyr as a Partner from Discovery Stage + Medical Devices o Market Access - Device Registration Americas * USA + e-Star + 513(g) + 510(k) + Q-submission + Pre-market Approval + RFD & Pre-RFD + UDI and GUDID Solutions for the FDA Compliance * Canada + Canada ISED Representative Service + Medical Device Establishment Licence (MDEL) Solutions for Canada + Medical Device Importer Solutions for Compliance in Canada + Medical Device Licence (MDL) Solutions for Canada - Device Registration Europe * CE Marking * EU MDR * EU IVDR * European Authorized Representative - Device Registration China - Device Registration South Korea - Device Registration Australia - Device Registration UK - Device Registration Switzerland - Device Registration: Rest of the World - In-Country Representation * Australian TGA Sponsor * Korean Registration Holder (KRH) * Mexican Registration Holder (MRH) * US Agent * Swiss Authorised Representative (CH-Rep) * UK Responsible Person (UKRP) * Designated Market Authorization Holder (DMAH) * China Agent Services * Brazil Registration Holder (BRH) * Indian Authorization Agent for Medical Device Registration in India * In-country representation Rest of the world o Post Market Surveillance - Product Complaints Management - Device Recall, Corrections and Removals - PMSP, PMSR, PMCF, PSUR, Annual Maintenance * Post-Market Surveillance (PMS) * Periodic Safety Update Report (PSUR) - Health Hazard Evaluation - Medical Device Translation Services o Medical Writing for Medical Devices - Clinical Evaluation * Clinical Evaluation Plan (CEP) * Clinical evaluation report (CER) - Performance Evaluation * Scientific Validity Report (SVR) * Clinical Performance Report (CPR) * Analytical Performance Report (APR) * Performance Evaluation for In Vitro Diagnostic Medical Devices * Performance EvaluationReport (PER) IVDR - Lifecycle Management - Literature Search Protocol and Review o Regulatory Affairs - Device Documentation * Device History File * Device Technical File Publishing - Labeling Services - Technical Writing Services - RA Staff Augementation Services - Regulatory Consulting * Life cycle management * Medical Device Consulting * IVD Consulting * SaMD Consulting * Combination product Consulting * Regulatory Intelligence * Device classification & Categorization - Human Factors Engineering for Medical Devices - Market Intelligence Service - Medical and Scientific Communication - Mergers and Acquisitions Regulatory Services - Biocompatibility Services for Medical Devices o Quality, Compliance, and Audit - QMS Consultancy Services - ISO 14971 Risk Management Consulting - QMS Remediation - Compliance & Audit Support - QMS Toolkit - Document Management - Corrective and Preventive Action Management Services - Supplier Evaluation o Digital Health/SaMD - SaMD Registration in the US - SaMD Registration in the EU - Global Market Expansion for SaMD - Regulatory Strategy Consultation for SaMD - Quality Management Systems Implementation o Artwork Services - Regulatory Artwork o Global Regulatory Intelligence - Global Regulatory Intelligence + Cosmetics o Cosmetics Services - Cosmetic Product Labeling Review - Cosmetic Safety Assessment and Toxicology Services - Global Regulatory Compliance and Consulting (GRCC) - Formulation and Ingredient Review - Cosmetic Product Information File (PIF) - Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) - Go-to-market and Legal Representative (LR) - EUDR Compliance Services for Cosmetics Industry o Cosmetics Service - Comprehensive Artwork Services for Cosmetics - Global Cosmetovigilence Services - Claims Review - Cosmetic Testing - Cosmetic Regulatory Intelligence - Global Regulatory Intelligence + Food Supplements o Food & Food Supplements Product Services - Food & Food Supplements Product Services - Food and Food Supplements Artwork Services - Global Regulatory Compliance and Consulting (GRCC) - Novel Food Support (NDIN, GRAS, NSF) - Raw Material Specification Compliance - Ingredients/Formulation Compliance - Claims Review, Substantiation, and Notification Support - Food and Food Supplement Classification: A Global Overview - Manufacturing Facility Registration Support (FFR/FBO/Site license) - Labeling Compliance - Dossier Compilation Support - Food Product Registration Service/Notification - Legal Representation (LR) Support - Regulatory Audit and Training Support (GMPs, GHP, HACCP) - Food Regulatory Pathway Reports o Sustainability Services - Sustainability Services - Recycling Logo Content and Design Support for Food and Food Supplements - Navigate EPR, PCR, PPWR & SUP Compliance with Confidence! - EU Deforestation Regulation Services - Ecolabelling Regulatory Support o Categories Supported - Categories Supported - Cultured Food Products Regulatory Compliance for (Animal & Plant-Based) - Dietary Supplement Regulation and Compliance - Ensure Global Compliance for Your Tobacco and Nicotine Products - Herbal Supplements (Botanical Extracts) - Infant Formula Regulatory Compliance - Medical Foods / FSMP - Organic Foods - Probiotics, Prebiotics, Postbiotics & Synbiotics - Processed Food Products - Traditional Medicines Regulatory Compliance - Alcoholic Beverages + Chemicals o CSRA Services - Chemical Data Scouting - Chemical Scientific Assessment Reports and Position Paper Report - Supply Chain Regulatory Compliance - Chemical Packaging Regulations - Global Biocidal Products Regulation Services - Regulation of Tobacco Products - Ecolabeling Regulatory Support - Chemical Safety Data Sheet (SDS) Authoring & Compliance Services - Household and Chemical Products Artwork Services - Sustainability Consulting Services o CSRA Services - Extended Safety Data Sheet (eSDS) Services - Global Regulatory Compliance and Consulting (GRCC) - Pet Care Products Registration - General Product Safety Regulation (GPSR) - Global REACH Regulatory Compliance - Chemical Toxicological Risk Assessment - EUDR Compliance Services for Chemical & general consumer product - Environmental Risk Assessment (ERA) Services - Global Regulatory Intelligence * Global Toggle submenu Americas Europe Asia-Pacific Africa & Middle East Global Americas Menu Block + Argentina + Bolivia + Brazil + Canada + Chile + Colombia + Costa Rica + Dominican Republic + Guatemala + Mexico + Panama + Paraguay + Peru + Puerto Rico + United States + Venezuela Global Europe Menu Block + Albania + Austria + Belarus + Belgium + Bulgaria + Croatia + Cyprus + Czech Republic + Denmark + Estonia + European Union + Finland + France + Germany + Greece + Hungary + Ireland + Italy + Kazakhstan + Kosovo + Latvia + Lithuania + Luxembourg + Macedonia + Malta + Netherlands + Norway + Poland + Portugal + Romania + Serbia + Slovakia + Slovenia + Spain + Sweden + Switzerland + United Kingdom + Uzbekistan Global Asia - Pacific Menu Block + Australia + Bangladesh + Cambodia + China + Hong Kong + India + Indonesia + Japan + Malaysia + New Zealand + Pakistan + Philippines + Singapore + South Korea + Sri Lanka + Taiwan + Thailand + Vietnam Global Africa & Middle East Menu Block + Algeria + Bahrain + Egypt + Ethiopia + Ghana + Iraq + Israel + Jordan + Kenya + Kuwait + Lebanon + Morocco + Nigeria + Qatar + Saudi Arabia + South Africa + Tunisia + Turkey + UAE + Uganda + Yemen + Zimbabwe + Americas o Argentina o Bolivia o Brazil o Canada o Chile o Colombia o Costa Rica o Dominican Republic o Guatemala o Mexico o Panama o Paraguay o Peru o Puerto Rico o United States o Venezuela + Europe o Albania o Austria o Belarus o Belgium o Bulgaria o Croatia o Cyprus o Czech Republic o Denmark o Estonia o Finland o France o Germany o European Union o Greece o Hungary o Ireland o Italy o Kazakhstan o Kosovo o Latvia o Lithuania o Luxembourg o Macedonia o Malta o Netherlands o Norway o Poland o Portugal o Romania o Serbia o Slovakia o Slovenia o Spain o Sweden o Switzerland o United Kingdom o Uzbekistan + Asia-Pacific o Australia o Bangladesh o Cambodia o China o Hong Kong o India o Indonesia o Japan o Malaysia o New Zealand o Pakistan o Philippines o Singapore o South Korea o Sri Lanka o Taiwan o Thailand o Vietnam + Africa & Middle East o Algeria o Bahrain o Egypt o Ethiopia o Ghana o Iraq o Israel o Jordan o Kenya o Lebanon o Morocco o Kuwait o Nigeria o Qatar o Saudi Arabia o South Africa o Tunisia o Turkey o UAE o Uganda o Yemen o Zimbabwe * Customers Toggle submenu + Success Stories + Case Studies + Testimonials * Insights Toggle submenu + Blogs + Brochures + Infographics + Webinars + Freyr Podcasts + What is ...? + White Papers + Fireside Chats + e-Books + Global Health Authority Mandates + Regulatory Roundup + Templates and Checklists + Industry News + Videos + Toolkits * Company Toggle submenu + About Us + Awards & Recognitions + Press Releases + Freyr in Media + Industry Events + Freyr Events + Careers + Compliance Wall + Corporate Social Responsibility + Functional Delivery Models + Partner with Us + Contact Us * Get in Touch * English + Japan (Japanese | English) + South Korea (Korean | English) + China (Chinese | English) + Mexico (Español | English) + Brazil (Portuguese | English) + Australia (English) + Sri Lanka (English) + India (English) + Malaysia (English) + Nigeria (English) + Saudi Arabia (English) + Thailand (English) * * + +1 908 483 7958 + +44 2037 012379 + +1 778 308 4671 + +49 6181 707 9007 + +52 55 41613365 + +65 315 894 72 + +62 604 2250544 + +91 40 4848 0999 + +61 2 8607 5105 + +41 225 087 129 * + sales@freyrsolutions.com + hr@freyrsolutions.com Breadcrumb 1. Home 2. Insights 3. Freyr Blogs Freyr Blogs Featured Blogs 2 min read January 2, 2026 Food Supplements EUDR 2025 Agreement: Deadlines Extended, Obligations Clarified, Scope Refined 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs Japan Implements ICH Guidelines for Generic Pharmaceuticals: What Global Manufacturers Must Prepare for by April 2026 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs India’s Transition Toward Mandatory eCTD Submissions: What Pharma Manufacturers Must Prepare for in 2026 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs Accelerating Market Entry in Australia: How Enhanced TGA Regulatory Pathways Support Faster Pharmaceutical Approvals 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs The Farmatag® Safety Label Malaysia Update - What’s Changing and Why It Matters to You PreviousNext * All * Medicinal Products * Medical Devices * Cosmetics * Food Supplements * Chemicals * Freyr Digital * 3 min read January 5, 2026 Medicinal Products, Publishing and Submission Regulatory Submission Checklists for 2026: FDA, EMA, MHRA, TGA, Health Canada * 3 min read January 5, 2026 Medicinal Products, Publishing and Submission How to Build a Submission-Ready Dossier: Freyr’s 2026 Compliance Framework * 3 min read January 5, 2026 Medicinal Products, Publishing and Submission Japan PMDA eCTD Best Practices for 2026 Submissions: A Practical, Submission-Ready Guide for Regulatory Teams * 2 min read January 2, 2026 Food Supplements EUDR 2025 Agreement: Deadlines Extended, Obligations Clarified, Scope Refined * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs OTC Registration Malaysia: 8 Key Things to Know * 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs Japan Implements ICH Guidelines for Generic Pharmaceuticals: What Global Manufacturers Must Prepare for by April 2026 * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs India’s Transition Toward Mandatory eCTD Submissions: What Pharma Manufacturers Must Prepare for in 2026 * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs Accelerating Market Entry in Australia: How Enhanced TGA Regulatory Pathways Support Faster Pharmaceutical Approvals * 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs The Farmatag® Safety Label Malaysia Update - What’s Changing and Why It Matters to You * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs 11 Must-Know FAQs: Pharmaceutical Product Approval in Nigeria * 3 min read December 11, 2025 Medicinal Products, Regulatory Affairs 6 Challenges in Regulatory Affairs in Pharmaceutical Industry in Philippines & solutions * 2 min read December 11, 2025 Medicinal Products, Regulatory Affairs Pharmaceutical Industry in the Philippines: An Emerging Hub for Growth Pagination * View More Blogs How can we help you? Please let us know your requirements, and we will contact you. You must have JavaScript enabled to use this form. Select IndustryMedicinal Products Medical DevicesCosmeticsFood SupplementsChemicals I have read the privacy policy Submitted Page URL Website URL Content Type Form Name Leave this field blank * Americas * Europe * Asia-Pacific * Africa & Middle East +1 908 483 7958 +44 203 701 2379 +91 40 4848 0999 +27 105 002 556 sales@freyrsolutions.com Connect with Us * * * * * Terms of Use | Privacy Policy | Cookie Policy © Copyright 2025 Freyr. All Rights Reserved. |
For now, Differences are performed on text, not graphically, only the latest screenshot is available.
Screenshot requires Playwright/WebDriver enabled