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.

  • 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.