CMC and Supply Chain
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.
- Gap Analysis and preparation of CMC sections of Japanese CTD M3, M 2.3 and M 1.2
- Support GMP compliance review
- 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
