COMPANY
NEWS
WHAT WE OFFER
LOCATION
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COMPANY
NEWS
WHAT WE OFFER
LOCATION

Regulatory Affairs

We provide consulting on the regulations and procedures required for pharmaceutical registration in Japan and support the most efficient registration through consultation with customers.

Process
Seminar on Japanese regulations
Establishment of development strategy
PMDA face-to-face consultation
Clinical (or BE) plan approval
Clinical trials
Application for approval
Item approval
Services
Support CTD creation
Establishment of permit registration strategy and preparation of various application materials
Confirmation of conformity with Japanese approval application regulations
Support for various consulting related to approval applications