REGULATORY AFFAIRS
4C Pharma Solutions

PRE APPROVAL

  • Strategic Support in Product Development RA approach
  • CMC Authoring / Compilation, DMF Authoring / Compilation
  • Liaise with agencies for Submission Slots, Requirements, and Feedback
  • Develop & Maintain Labelling activities
  • Development of Regulatory SOPs
4C Pharma Solutions

THROUGH APPROVAL

  • MAA, ANDA, NDAs support and other global submissions
  • Dossier/Technical File Compilation, Writing and Submission for all types of Applications
  • Variations/Annual Reports and Renewal Applications
  • Variations/Annual Reports and Renewal Applications
  • Safety and Quality Updates and PSUR Submissions
  • Regulatory Assessment of change controls for Submitted/Approved Products
  • Maintenance of Regulatory Databases
4C Pharma Solutions

LABELLING & ARTWORK

  • Labeling Updates and Amendments and Country Specific Label Conversions
  • Author, Update and Amend CCDS
  • Readability Testing for PILs, Package Inserts
  • Artwork Preparation
  • Preparation/Review of Promotional Material

Global Regulatory Affairs Feature

4C Pharma Solutions-Regultory Affairs
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