REGULATORY AFFAIRS SOLUTIONS

Explore our comprehensive Regulatory Affairs Solutions, designed to ensure your pharmaceutical endeavors meet the highest standards of compliance and regulatory requirements.

Learn More

An Overview of our Regulatory Affairs Solutions

Global / Country Specific Submissions

Lifecycle Management Support

Conversion from NeeS/CTD to eCTD with in-house eXtedo eCTD Manager

CTD, NeeS, eCTD Preparation

CCDS / CCSI / USPI / PIL / SPL authoring and periodic updates

Artwork & Documentation

Regulatory Affairs

Records Management

Partnering with you at every milestone​

4C Pharma Solutions provides unparalleled Regulatory Affairs solutions, standing by you to ensure a seamless journey through compliance and regulatory excellence.

Learn more
Regulatory Affairs Solutions

Pre-Approved

  • Dossier submission to the Agency
  • Response to Agency queries
  • Clinical and non-clinical activities
  • Create Master dossier / documents
  • Labeling
  • Dossier compilation as per Agency’s required format

APPROVAL / REJECTION

  • Marketing Authorization Applications (MAA) for Europe
  • ANDA, NDAs for US
  • Medical Devices
  • Food supplements
  • Over the counter drugs
  • Biological Licensing Applications.

POST MARKETING

  • European Variations
  • NDA/ANDA supplements compilation and submission
  • Renewal Applications
  • Change Control Management
  • PSUR’s Submissions
  • Labeling Updates

Labelling and Artwork Solutions

Explore our Regulatory Affairs Solutions, including comprehensive Labelling and Artwork Solutions, to ensure your products meet all compliance and regulatory standards.

✓

Labeling updates and amendments and Country specific label conversions

✓

Author, update and amend CCDS

✓

Readability testing for PILs, package inserts

✓

Artwork operations and Preparation / review of promotional material

For any regulatory requirements, please provide your details below to access our expert Regulatory Affairs Solutions

Drop in you requirements here
4C Pharma Solutions

Drop in your details for more info

Please fill in your details below