Regulatory Service and Support – Commercial Phase

 

  • Compilation of the drug substance CTD sections of Module 1, 2 and 3 for a NDA/MAA submission
  • The CTD sections can be prepared either in PolyPeptide’s template or in any client template
  • Compilation and submission of DMF/ASMF in any market
  • Compilation and submission for CEP (COS) certificate
  • DMF/ASMF/CEP on file at regulatory authorities for many generic drug substances
  • Access to open part DMF for client’s submission in less regulated markets
  • Professional support in responding to review questions from regulatory authorities
  • Life cycle maintenance of all regulatory dossiers, independent on the submission route
  • Preparation and submission of variations and changes
  • Advice and strategies for obtaining regulatory approval
  • Close and transparent collaboration with clients