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

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 stands by you for all your Regulatory Affairs requirements, ensuring a seamless journey through compliance and regulatory excellence.



  • 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


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


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

Labelling and Artwork Solutions

Trust us to elevate your product's image through meticulous attention to detail in every aspect of Labelling and Artwork.

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

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4C Pharma Solutions

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