Though we are under ICH progress, there are still some gaps between foreign countries and Japan. Analyses what are missing and insufficient are the essential activities before starting to enter into Japanese market.
We will analyse the documents to find the gaps and report to the clients in English.

We are specialized in CMC Regulatory Requirements matters.
It is important to understand what about JP, Test Methods, Stability Study requirements before starting the clinical development and MA registration works.

Market analyses (such as size, competitor, products under development, NHI price expectation, etc.) are also one of the essential point for the entry planning to Japanese market.
We will collect those information and analyse to report you in English.

We provide the services in selecting the licensing partner candidates with their background information.