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.
Multidisciplinary global team
Our team is composed of world-class experts with 30+ years of Japan experience.
Integrated robust strategy
We cover Regulatory Affairs, Drug Development, Licensing and Commercial Strategy.
Flexible and client focused
We are agile with strong focus on our clients. We cater our services to meet their unique needs.
We are a perfectly bilingual team with a culturally-sensitive communication style.