Regulatory Affairs
We provide a full range of Regulatory services
These include the following:
Regulatory Strategy
- Independent assessment report on development and registration pathways in Japan.
- Integration of Japan into global regulatory strategy.
- Regulatory requirements during development and for registration (CMC, Non-clinical and Clinical).
- Japan-specific Precedence analysis & Regulatory Intelligence.
Conditional Approval
- Exploring eligibility for conditional approval, Strategy, Preparation of Docs and F2F meetings with PMDA. Etc.
PMDA Scientific Advice
- Support includes all aspects starting from Strategy, preparation of Docs, F2F meetings and daily interactions with PMDA.
Orphan Drug Designation
- Support includes all areas related to orphan designation (Strategy, Preparation of Docs and F2F meetings with MHLW).
Japan NDA
- Gap Analysis, Preparation and review of CTD (CMC, non-clinical and clinical), submission of NDA and support during interactions with PMDA.