Regulatory Strategy

Identify optimal clinical trial strategy (filing in US vs. Europe vs. Asia)

Facilitate the preparation, rehearsal, presentation for any Agency Meetings and subsequent re-evaluation of clinical plan

Critique Regulatory Documents for completeness and accuracy to avoid deficiencies

  • Investigational New Drug Application (IND)
  • Biological License Application (BLA)
  • Abbreviated New Drug Application for Generics (ANDA)
  • Common Technical Document (CTD)
  • Certificate of Foreign Governments
  • Advertisement standards for print, television, infomercials, radio and Internet promotion of therapeutics