CMC & Supply Chain
Exceptionally strong CMC team
CMC is one of the most challenging aspects of Japanese regulatory requirements, but we pride ourselves in having an exceptionally strong CMC team. We cover various aspects related to CMC for small molecules, large molecules, ADCs and regenerative medicine products:
Support on CMC regulatory framework and requirements for supply chain of commercial and investigational product in Japan.
Support GMP compliance review
Gap Analysis and preparation of CMC sections of Japanese CTD M3, M 2.3 and M 1.2
Management of variations in Japan
Selection of potential distributors/CMOs in Japan for potential support – QC Release requirements in Japan
- Technology transfer
- Support in negotiation until agreement is signed with CMOs/distributors
We are your gateway for success in Japan
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