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