• KM helps define regulatory strategy from IND to NDA we can
    • Select regulatory experts and Advisory Board
    • Prepare meetings with Development Advisory Board
    • Advise on a regulatory strategy to NDA
    • Generate development plan based on the regulatory strategy
    • Manage pre-clinical studies for IND filing
    • Organize meetings with FDA (pre-IND, type C; etc)
  • KM can manage IND/NDA/BLA submissions