Services - regulatory affairs
Regulatory Affairs is crucial to all phases of clinical development, especially for global trials. The DOT regulatory affairs team has broad experience and provides the best path for clinical development in Japan. DOT negotiates directly with the Japanese authority, PMDA which expedites your development/marketing plans in Japan.
- Consulting for development strategies
- Advising on regulatory issues
- Reviewing regulatory submissions
- Negotiating with the PMDA
- Preparing documents for PMDA negotiation
- Preparing Common Technical Document (CTD)
- Development strategy consulting
- Management of the registration procedure
- Supporting New Drug Applications (NDA)
- Supporting Pharmacovigilance
