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      Regulatory Pathways for Cosmetics Registration in...
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      October 11 2023 03:00 PM
      Cultivating NSF Compliance: Your Path to...
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  - 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
    
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  - We offer 360 degree regulatory solutions to – Drugs, Biologicals, Medical Device, In-Vitro Diagnostics, Food, Nutraceuticals, Cosmetics.

in India

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CliniExpert-usp test license

– Overview

Who Can Apply?

How To Apply?

The Applicant must follow the following process:

Important Documents

Important Documents

Timeline to get from

Essential Tips

For Importers Globe Icon

For Importers To India

For Importers CTA Button

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 Gear Icon

For Manufacturer To India

For Manufacturer CTA Button

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

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

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.

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ISO 27001

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Office

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

Call us on

Sales: +91 7672005050
Reception: +91-11-45214546

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contact@cliniexperts.com

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