Regulatory Affairs(RA) and Medical Writing(MW)

We understand that there are various situations where you may require support for RA-/MW-related tasks, such as Drug Master File registration, obtaining foreign manufacturer certification, consultation with PMDA (e.g., regulatory strategy consultations, Cartagena consultations, clinical trial consultations (pre-Phase I trial initiation, End of Phase II trial, pre-NDA, etc.)), IND/clinical trial initiation procedures, orphan drug designation applications, preparation of submission dossiers(CTD/STED).

Those requests seem to be categorized into two types. The one is a support to proceed the RA process efficiently based on the understanding of the pharmaceutical regulatory system in Japan. The other is a strategic support, which involves consulting with regulatory authorities to determine the direction of the project for Japan approval (or how to reach agreement with regulatory authorities to align with company strategy).

We are diverse team with extensive RA experience including English capability, and we have a confident to support your request from both efficient procedure in Japan and strategic aspect for Japan approval.

In particular, I have experienced to work for over 30 years at the Japanese subsidiary of a large European pharmaceutical company, where I was involved in aligning development/approval strategies between US/Europe and Japan, and have participated in numerous PMDA consultations. Based on those experiences, we will become a reliable Japanese partner that not only resolves the current issues at hand but also finds the solutions with forward-looking attitude for your final goal.