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.
- 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).
- Conditional Approval
Exploring eligibility for conditional approval, Strategy, Preparation of Docs and F2F meetings with PMDA. Etc.
- Japan NDA
Gap Analysis, Preparation and review of CTD (CMC, non-clinical and clinical), submission of NDA and support during interactions with PMDA.