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