Services
Regulatory
- 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