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        +91 7672005050 contact@cliniexperts.com
              * For Importer
                  + PRODUCT CATEGORIES
                      o Drug

                        Understand all the aspects of Drug Import License and Regulatory Support

                      o Biological

                        Effortless pathways to bring innovative biologicals to the Indian market.

                      o Medical Device

                        Navigating Medical Device Compliance for Import Success

                      o Food

                        Your trusted gateway to hassle-free food imports into India.

                      o IVD

                        Streamlining IVD imports with precision and compliance

                      o Cosmetic

                        Accelerate your Cosmetic business in India with professionals' assistance.

                      o Food Supplements

                        Empowering Importers with Insights and Strategies for Functional Food Supplement Import.

                  + REGULATORY BODIES
                      o CDSCO

                        Navigate Central Drugs Standard Control Organization regulations and approvals.

                      o FSSAI

                        Explore Food Safety and Standards Authority of India requirements and certifications.

                      o Legal Metrology

                        Comply with legal metrology regulations for accurate measurements and labeling.

                      o BIS

                        Understand Bureau of Indian Standards for quality assurance and product compliance.

                      o WPC

                        Wireless Planning and Coordination regulations for wireless communication equipment.

                      o CBN

                        Enforce Compliance and Regulations by the Central Bureau of Narcotics.

                      o CDSCO - East Zone

                      o CDSCO - North Zone

                      o CDSCO - West Zone

                      o CDSCO - South Zone

                  + AUTHORIZED AGENT IN INDIA

                              Regulatory Intelligence And Strategy With our years of expertise, collaborations and strong network of industry contacts, we provide insightful analys...

                              Read more

                            o ENQUIRE NOW

                              As regulatory solutions providers, we offer a wide variety of services and products that assist our customers through every stage of the regulatory process by simplifying, educating and supporting them.

                              ENQUIRE NOW
              * For Manufacturer
                  + PRODUCT CATEGORIES
                      o Drug

                        Wide array of pharmaceutical solutions adhering to regulatory standards.

                      o Biological

                        Effortless pathways to bring innovative biologicals to the Indian market.

                      o Medical Device

                        Get an insight for all Regulatory Services for Medical Device Manufacturers.

                      o Food

                        Your trusted gateway to hassle-free food imports into India.

                      o IVD

                        Understand the comprehensive consulting services for IVD manufacturers.

                      o Cosmetic

                        Know more about cutting edge regulatory solutions for cosmetic manufacturers.

                      o Food Supplements

                        Exploring Functional Food Supplements for Manufacturers

                  + REGULATORY BODIES
                      o CDSCO

                        Navigate Central Drugs Standard Control Organization regulations and approvals.

                      o FSSAI

                        Explore Food Safety and Standards Authority of India requirements and certifications.

                      o Legal Metrology

                        Comply with legal metrology regulations for accurate measurements and labeling.

                      o BIS

                        Understand Bureau of Indian Standards for quality assurance and product compliance.

                      o WPC

                        Wireless Planning and Coordination regulations for wireless communication equipment.

                      o CBN

                        Enforce Compliance and Regulations by the Central Bureau of Narcotics.

                      o CDSCO - East Zone

                      o CDSCO - North Zone

                      o CDSCO - West Zone

                      o CDSCO - South Zone

                  + BLOGS
                              o Regulation/Guidelines

                                Regulatory Due Diligence for Medical Devices:...

                                Read more
                                Regulation/Guidelines

                                Top FAQs on CDSCO Medical Device...

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                              VIEW ALL

                            o PHARMACEUTICAL QUALITY AND COMPLIANCE SERVICES

                              Learn how pharmaceutical and compliance services help navigate regulations, optimize processes, and maintain quality across the industry.

                              READ MORE
              * Authorized Agent in India
                  + PRODUCT CATEGORIES
                      o Drug

                        Streamline all your regulatory approvals of drugs with the guidance of authorized agents.

                      o Biological

                        Get the guidance of authorized agent for biologicals registration and licensing.

                      o Medical Device

                        Guidance for medical device importers to their regulatory triumph.

                      o Food

                        Assistance for importing food in India approved by FSSAI.

                      o IVD

                        Assistance of authorized agents for your path to IVDs authorization.

                      o Cosmetic

                        360 degree regulatory solutions starting from documentation to marketing of cosmetics.

                  + AUTHORIZED AGENT IN INDIA

                              Regulatory Intelligence And Strategy With our years of expertise, collaborations and strong network of industry contacts, we provide insightful analys...

                              Read more

                            o ENQUIRE NOW

                              As regulatory solutions providers, we offer a wide variety of services and products that assist our customers through every stage of the regulatory process by simplifying, educating and supporting them.

                              ENQUIRE NOW
              * About Us
                  + RELATED WEBSITES
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                  + NEWS & PRESS RELEASE
                          o Drug and Medical Device Regulatory Dynamics in India – CliniExperts is Acing the Ace
                          o CBIC honours CliniExperts for Outstanding GST Compliance in FY 2023-24
                          o CliniExperts – Most Promising Medical Device & Pharmaceutical Regulatory Consultant From Asia
                        o VIEW ALL
                  + ABOUT COMPANY

                            o End-to-End Regulatory Solutions for Domestic and International Markets.

                              We are a regulatory solutions provider serving the Drugs, Medical Devices, Biological, IVDs, Neutraceuticals, Food, and Cosmetic industries. We are committed to simplify, familiarize, and support our clients through every step of the regulatory journey.

                              ENQUIRE NOW
                  + ENQUIRE

                            o As regulatory solutions providers, we offer a wide variety of services and products that assist our customers through every stage of the regulatory process by simplifying, educating and supporting them.

                              ENQUIRE NOW
              * Clients
                  + TESTIMONIALS

                          o I want to extend my sincerest thanks for your diligent work and effort in submitting the claim approval application to the Regulatory...

                            Dr Nikhil Teli | Manager - Innovation, GCViDeal (A GCV Life Pvt. Ltd. Company)

                          o We’re happy with the Regulatory services rendered and support by CliniExperts for our company as they execute the projects diligently keeping all...

                            Nagaraj G P | Randox Labortaroies

                          o We appointed Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much ...

                            Mr. Faiyaz | Unity Enterprises

                        o VIEW ALL
                  + OUR HAPPY CLIENTS

                            o We are fortunate to have several reputed clients as our partner in progress.

                                We work with the best companies from across the world. Our clients are well known globally for their high-quality products, services, post-sales service and customer care. They come with a commitment to be a part of the Indian Healthcare Sector.

                                We work with companies from Drugs, Biologicals, Medical Devices, In-Vitro Diagnostics, Foods, Neutraceuticals, Cosmetics and more.

                              VIEW OUR CLIENTS
                  + ENQUIRE

                            o As regulatory solutions providers, we offer a wide variety of services and products that assist our customers through every stage of the regulatory process by simplifying, educating and supporting them.

                              ENQUIRE NOW
              * Resources
                  + KNOWLEDGE BOX
                              o Regulation/Guidelines

                                Regulatory Due Diligence for Medical Devices:...

                                Read more
                                Regulation/Guidelines

                                Top FAQs on CDSCO Medical Device...

                                Read more
                              VIEW ALL
                      o WEBINAR
                                  - November 7 2025 03:00 PM

                                    Aligning with Global Standards: Understanding the...

                                    Read more
                                    June 20 2024 02:45 PM

                                    Regulatory Pathways for Cosmetics Registration in...

                                    Read more
                                  VIEW ALL
                  + REGULATORY UPDATES

                            o Draft Rules on the Legal Metrology Government Approved Test Centre Amendment Rules, 2026 for comments from stakeholders

                              WEIGHING SCALES

                              o 2025.12.29_ S.O. 6091(E)_Notification regarding Nimesulide above 100 mg in immediate release dosage form

                                DRUG

                                o Implementation of Standardized Format for submission of representation seeking risk assessment

                                  FOOD SUPPLEMENTS AND NUTRACUETICALS FOOD

                                  o Notification of Manufacturers under Rule 54 of NDPS Rules, 1985 (Effective for the period upto 31st December, 2027)

                                    DRUG NARCOTICS

                                    o New provision for Risk Classification of Medical Devices on the CDSCO Online System for Medical Devices

                                      MEDICAL DEVICE
                                  o VIEW ALL
                                o INDIA REGULATORY EXPERT SERIES
                                          - Authorized Agent Support For Medical Devices
                                            Medical Device and IVD Import License/Approval in India
                                        VIEW ALL
                                o COVID INSIGHTS
                                          - COVID-19 Home Testing Using Rapid Antigen Tests (RATs) June 10, 2021
                                            CDSCO Provides Guidelines For Approval Of COVID-19 Vaccines For Restricted Use In An Emergency Situation In India And For The Import Of Vaccine By The Private Sector June 2, 2021
                                        VIEW ALL
                                o Contact Us
                                    - ENQUIRE

                                              * As regulatory solutions providers, we offer a wide variety of services and products that assist our customers through every stage of the regulatory process by simplifying, educating and supporting them.

                                                ENQUIRE NOW
                                    - OFFICE

                                              * CliniExperts have its premises in Delhi as well as Bengaluru. You can meet us at:

                                                USA
                                                601 N Mur-Len Road, Ste 9, Olathe, KS 66062
                                                +1 (337) 595-5127

                                                New Delhi
                                                Unit No. 324 & 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, India - 110075
                                                +917672005050

                                                Bengaluru
                                                RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka, India – 560064

                                                Singapore
                                                10 Anson Road, #11-20, International Plaza,Singapore (079903)

                                                CONTACT US
                                    - SUBSCRIBE TO LATEST NEWS

                                              * We offer 360 degree regulatory solutions to – Drugs, Biologicals, Medical Device, In-Vitro Diagnostics, Food, Nutraceuticals, Cosmetics.


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                  Regulatory Bodies

                        * Accredited notified body
                        * Animal Husbandary
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                        * NIB
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                        * State Ayush
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                        * Tea Board
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                  Product Categories

                          *   Ayurvedic Drug
                            
                          *   Biological
                            
                          *   Biological Samples - ICMR
                            
                          *   Biologicals
                            
                          *   Blood Products
                            
                          *   Cosmetic
                            
                          *   Diagonostic Kit
                            
                          *   Drug
                            
                          *   Electronic accessories
                            
                          *   Food
                            
                          *   Food Supplements and Nutracueticals
                            
                          *   Functional Food
                            
                          *   Functional Food
                            
                          *   House hold commodities
                            
                          *   IVD
                            
                          *   Laboratory equipment
                            
                          *   Medical Device
                            
                          *   Meters
                            
                          *   Narcotics
                            
                          *   Packaged Commodity
                            
                          *   Pesticides & Insecticides
                            
                          *   Pharmaceutical
                            
                          *   Phytopharmaceutical Drug
                            
                          *   Ready Made Garments
                            
                          *   Samd
                            
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                              Title of Update                                                                                                                                                                                                                        Regulatory Body   Product Category                          Type of Update  Date of Update  Enforcement Date  Link of Update
                              Draft Rules on the Legal Metrology Government Approved Test Centre Amendment Rules, 2026 for comments from stakeholders                                                                                                                Consumer Affairs  Weighing Scales                           Draft           01-Jan-2026     01-Jan-2026       Link          
                              2025.12.29_ S.O. 6091(E)_Notification regarding Nimesulide above 100 mg in immediate release dosage form                                                                                                                               CDSCO             Drug                                      Notice          30-Dec-2025     29-Dec-2025       Link          
                              Clarification regarding the use of the word “Tea”                                                                                                                                                                                      FSSAI             Food                                      Notice          24-Dec-2025     24-Dec-2025       Link          
                              Implementation of Standardized Format for submission of representation seeking risk assessment                                                                                                                                         FSSAI             Food Supplements and Nutracueticals Food  Notice          24-Dec-2025     01-Jan-2026       Link          
                              LM General 7th amendment rules 2025                                                                                                                                                                                                    Consumer Affairs  House hold commodities Weighing Scales    Gazette         22-Dec-2025     18-Dec-2025       Link          
                              Compliance of Scheme of Testing for Packaged Drinking Water & Mineral Water                                                                                                                                                            FSSAI             Food Supplements and Nutracueticals Food  Notice          19-Dec-2025     01-Jan-2026       Link          
                              2025.12.04_ G.S.R. 883(E)_Draft Notification for amendment in Medical Device Rules, 2017                                                                                                                                               CDSCO             IVD Medical Device                        Notice          15-Dec-2025     15-Dec-2025       Link          
                              Notification of Manufacturers under Rule 54 of NDPS Rules, 1985 (Effective for the period upto 31st December, 2027)                                                                                                                    CBN               Drug Narcotics                            Notice          10-Dec-2025     10-Dec-2025       Link          
                              Notification regarding amendment in Form No. 4A (Import Certificate for Import of Narcotics Drugs under Rule 54) and Form No. 5 (Export Authorization for Export of Narcotics Drugs and Psychotropic Substances) of NDPS Rules, 1985.  CBN               Narcotics                                 Notice          10-Dec-2025     10-Dec-2025       Link          
                              New provision for Risk Classification of Medical Devices on the CDSCO Online System for Medical Devices                                                                                                                                CDSCO             Medical Device                            Notice          05-Dec-2025     04-Dec-2025       Link          
                              MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook                                                                                                                                                                              CDSCO             IVD Medical Device                        Draft           05-Dec-2025     05-Dec-2025       Link          
                              The Legal Metrology (General) Sixth Amendment Rules, 2025. – Breath Analyser                                                                                                                                                           Consumer Affairs  House hold commodities Weighing Scales    Gazette         04-Dec-2025     01-Apr-2026       Link          
                              LM packaged commodities second amendment rules 2025                                                                                                                                                                                    Consumer Affairs  Food                                      Gazette         02-Dec-2025     02-Dec-2025       Link          
                              Enforcement Action Against Use of Industrial Dye Auramine in Food Products such as Roasted Chana and Other Product                                                                                                                     FSSAI             Food                                      Notice          30-Nov-2025     28-Nov-2025       Link          
                              NPPA has fixed retail prices of 11 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 140th Authority meeting dated 27.11.2025                                                                             NPPA              Drug                                      Gazette         28-Nov-2025     05-Jan-2026       Link          
                              
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                                    For Importers To India

                                    Drug

                                      * Post Approval Changes for Drug
                                      * Test License to Import Drugs in India
                                      * Authorized Agent in India for Drug
                                      * Wholesale License Form 20B
                                      * Regulatory Services For Drug License
                                      * Drug Marketing Authorization Approval in India
                                      * Drug registration certificate
                                      * Drug Re-registration in Form 40
                                      * Permission of Repacking Under Rule 37
                                      * Import License
                                      * Advanced Shelf Life Extension

                                    Biologicals

                                      * Authorized Agent in India for Biologicals
                                      * Registration
                                      * Post Approval Changes for Biologicals
                                      * Import License - Form 10
                                      * Marketing Authorization Approval

                                    Food Supplements

                                      * Food Product Compliance
                                      * Form C
                                      * Non Specified Product / Ingredient Approval
                                      * Claim Approval
                                      * FSSAI Advertisement Claim Approval
                                      * Functional Food Supplement

                                    Medical Device

                                      * Authorized Agent in India for Medical Device
                                      * Import license (Form MD 14, 15)
                                      * New Medical Device permission (Form MD 26, 27)
                                      * Registration Number for Non-Notified Medical Devices
                                      * Clarification regarding Medical Devices
                                      * Permission to conduct clinical investigation (Form MD-22, 23)
                                      * Post Approval Change- Major/ Minor
                                      * Pre-Conception & Pre-Natal Diagnostic Techniques Certificate from PC & PNDT Authority
                                      * Assistance in ISO 13485 Certification
                                      * Label compliance
                                      * WPC - ETA Approval
                                      * Medical Device for Importer
                                      * WPC Framework For Wireless Medical Devices
                                      * Permission To Import Medical Devices Test License
                                      * Sugam Registration For Medical Devices
                                      * New Medical Device License For Manufacturer – Form MD 26 MD 27
                                      * Registration of Class a Non-sterile and Non-measuring
                                      * EPR Authorization Certificate from CPCB
                                      * E-waste EPR Registration Post compliance

                                    IVD

                                      * Authorized Agent in India for IVD Import License (Form MD 14, 15)
                                      * Import License (Form MD 14, 15)
                                      * Registration Number for Non-Notified In Vitro Diagnostic
                                      * Label Compliance for IVD
                                      * Free Sale Certificate
                                      * Test License to import In-vitro diagonostics
                                      * Permission to conduct Clinical Performance Evaluation (Form MD 24, 25)
                                      * Assistance in ISO 13485 Certification
                                      * Clarification Letter / No Objection Certificate
                                      * Post Approval Changes
                                      * Retention of IVD Import License
                                      * Permission For Import Predicate IVD Kit License CDSCO Form Md 14 15

                                    Food

                                      * Food Product Compliance
                                      * Form C
                                      * Non Specified Product / Ingredient Approval
                                      * Claim Approval
                                      * FSSAI Authorized Agent Support
                                      * FSSAI Annual Return Filing
                                      * Modification of FSSAI License
                                      * Registration of Foreign Food Manufacturing Facilities
                                      * Sanitary Import Permit
                                      * FSSAI License Renewal

                                    Cosmetic

                                      * Authorised agent in India for cosmetics
                                      * Permission to Import/manufacture new cosmetics in India
                                      * Fresh Registration (Cos-2)
                                      * Cosmetic - Product Compliance
                                      * Post Approval Changes For Cosmetics

                                    Other

                                      * Legal Metrology - Registration of Importer under Rule 19
                                      * Legal Metrology - Label Compliance
                                      * Legal Metrology - Registration of Manufacturers, Importers and Packers (Packaging and Warehouse Registration) under Rule 27
                                      * Legal Metrology - Model Approval
                                      * Wholesale License Form 20B
                                      * Legal Metrology Services
                                      * India Regulatory Expert Series
                                      * Regulatory Updates Repository

                                    For Manufacturer in India

                                    Drug

                                      * Test License to Manufacture Drug in India
                                      * New Drug Approval
                                      * Wholesale Drug License Form 20B and 21B
                                      * Manufacture Formulation Of Unapproved API Drugs
                                      * Permission For Drug Manufacturing License
                                      * Investigational New Drug (IND) Application
                                      * Subsequent New Drug Approval (SND)
                                      * Manufacture Unapproved API For Development of Formulation for Test / Analysis / CT / BA / BE – CT 15
                                      * Pharmaceutical Quality And Compliance Services
                                      * Good Manufacturing Practices (GMP)

                                    Biologicals

                                      * Permission For Clinical Trial Phase 1, 2, 3 – CT 04 and CT 06
                                      * CDSCO Manufacturing License for Biologicals
                                      * Marketing Authorization Approval
                                      * NOC for form 29 - Clarification Letter
                                      * Test License to Manufacture Biologicals

                                    Food Supplements

                                      * Food Product Compliance
                                      * Form C
                                      * Non Specified Product / Ingredient Approval
                                      * Claim Approval
                                      * FSSAI Advertisement Claim Approval
                                      * Functional Food Supplement Manufacturer

                                    Food

                                      * Food Product Compliance
                                      * Form C
                                      * Non Specified Product / Ingredient Approval
                                      * Claim Approval
                                      * FSSAI Authorized Agent Support
                                      * FSSAI Annual Return Filing (Form D1)
                                      * Modification of FSSAI License / Registration
                                      * FSSAI Registration of Foreign Food Manufacturing Facilities (ReFoM)
                                      * FSSAI License Renewal

                                    Medical Device

                                      * Permission to Manufacture Class B Medical Devices (Form MD 3, 5)
                                      * Permission to Manufacture Class C & D Medical Devices (Form MD 7, 9)
                                      * New Medical Device permission (Form MD 26, 27)
                                      * Registration Number for Non-Notified Medical Devices
                                      * Permission to conduct clinical investigation (Form MD-22, 23)
                                      * Post Approval Change- Major/ Minor
                                      * Pre-Conception & Pre-Natal Diagnostic Techniques Certificate from PC & PNDT Authority
                                      * Assistance in ISO 13485 Certification
                                      * Label compliance
                                      * WPC - ETA Approval
                                      * Test license to Manufacture Medical Devices (Form MD 12, 13)
                                      * Medical Device for Manufacturer Services
                                      * Registration of Class a Non-sterile and Non-measuring Medical Device
                                      * Clarification Letter Or No Objection Certificate (NOC)
                                      * Loan License To Manufacture Medical Devices Class C D
                                      * Loan License To Manufacture Medical Devices Class A B
                                      * Free Sale Certificate
                                      * Sugam Registration
                                      * Medical Device Class A B Manufacturing License
                                      * Medical Device Class C D Manufacturing License
                                      * New Medical Device License For Manufacturer
                                      * Retention Of Loan License To Manufacture Medical Device
                                      * Retention of Medical Device Manufacturing License For Class C- D
                                      * WPC Framework For Wireless Medical Devices
                                      * EPR Authorization Certificate from CPCB
                                      * E-waste EPR Registration Post compliance
                                      * EU Regulatory Due Diligence for Medical Devices
                                      * Canada Regulatory Due Diligence for Medical Devices
                                      * Australia Regulatory Due Diligence for Medical Devices
                                      * UKCA Regulatory Due Diligence for Medical Devices
                                      * US Regulatory Due Diligence for Medical Devices

                                    IVD

                                      * Permission to Manufacture Class A & B In Vitro Diagnostics (Form MD 3, 5)
                                      * Permission to Manufacture Class C & D In- Vitro Diagnostics(Form MD 7, 9
                                      * Registration Number for Non-Notified In Vitro Diagnostic
                                      * Label Compliance for IVD
                                      * Free Sale Certificate
                                      * Permission to conduct Clinical Performance Evaluation (Form MD 24, 25)
                                      * Assistance in ISO 13485 Certification
                                      * Permission for test license to manufacture in-vitro diagnostics
                                      * In Vitro Diagnostic Device Manufacturing License
                                      * Clarification Letter / NOC for IVD
                                      * In-Vitro Diagnostic Kits Sugam License
                                      * Permission for loan license to manufacture in-vitro diagnostic kits
                                      * Permission of Predicate In-Vitro Diagnostics Kit Loan License
                                      * Predicate In Vitro Diagnostics in Manufacturing License (Form MD 3, MD 5)
                                      * Permission for loan license to manufacture in-vitro diagnostic kits (IVD) for class C D Services
                                      * In-Vitro Diagnostic IVD Class A B Manufacturing License
                                      * In-Vitro Diagnostic IVD Class C D Manufacturing License
                                      * New In-Vitro Diagnostic License For Manufacturer
                                      * Endorsement Of Loan License For Predicate In-Vitro Diagnostic Manufacturer (MD 8 / MD 10)

                                    Cosmetic

                                      * Cosmetic Manufacturing License
                                      * Cosmetic - Product Compliance
                                      * Permission to Import/manufacture new cosmetics in India

                                    Other

                                      * Legal Metrology - Label Compliance
                                      * Legal Metrology - Registration of Manufacturers, Importers and Packers (Packaging and Warehouse Registration) under Rule 27
                                      * Legal Metrology - Model Approval
                                      * Wholesale License Form 20B
                                      * Legal Metrology Services
                                      * India Regulatory Expert Series
                                      * Regulatory Updates Repository

                                We offer 360 degree regulatory solutions to – Drugs, Biologicals, Medical Device, In-Vitro Diagnostics, Food, Nutraceuticals, Cosmetics.


                                    Please leave this field empty.

                                  Quick Link

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                                  Office

                                    USA
                                    601 N Mur-Len Road, Ste 9, Olathe, KS 66062
                                    +1(337)595-5127

                                    New Delhi
                                    Unit No. 324 & 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, India - 110 075 +91 7672005050

                                    Bengaluru
                                    RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka, India – 560064

                                    Singapore
                                    10 Anson Road, #11-20, International Plaza,Singapore (079903)

                                  Call us on

                                  Sales: +91 7672005050
                                  Reception: +91-11-45214546
                                  USA Phone No.: +1(337)595-5127

                                  E-mail us on

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