Regulatory Affairs

For assistance with regulatory affairs, our team is highly-experienced and well- trained. We can help you with:

  • Common Technical Document (CTD) format dossiers, clinical sections 2.5 and 2.7
  • Integrated summaries for NDAs
  • Clinical trial applications (CTA/IND) and annual updates
  • Briefing documents
  • Reports and executive summaries
  • Clinical expert statements
  • Query management