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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