Regulatory Service and Support – in Development and Clinical Phase

 

  • Compilation of the drug substance sections for an IND/IMPD/CTA in any market
  • The CTD sections can be prepared either in PolyPeptide’s template or in any client template
  • The content of the drug substance sections fulfill both US FDA and EU EMA requirements
  • Response to questions from clients and regulatory authorities within short timelines
  • Updates and amendments of the drug substance sections throughout development/clinical phases
  • Advice and strategies for obtaining regulatory approval
  • Close and transparent collaboration with clients