Regulatory Affairs

  • Dossier/submission preparation or review and filing
  • Pre-meeting packages, INDs/CTAs/IDEs and post-filing submissions, BLA/NDA/NDS/MAA/510(k)/PMA filings (US, Canada, EU)
  • Submission preparation to other worldwide agencies in European countries, South America, Australia, Asia, and ROW
  • Development of regulatory strategy for the product’s life cycle
    • Consideration of international regulatory requirements
    • Meeting international filings
    • Revision of plans as guidelines change
  • Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
    • Respond to regulatory agency questions
  • Regulatory classification of products across different jurisdictions
  • Provide expert regulatory CMC compliance advice throughout the development
  • Work with Sponsors and regulatory authorities through the resolution of complex development issues