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CMC
CoreMed manages all of the regulatory aspects of CMC, and establishes and implements strategies to support the entire development process from drug discovery to regulatory approval. CoreMed is familiar with Japan specific CMC requirements and ensures successful marketing approval. CMC documents are directly related to the “Certificate of Approval” which is binding and subject to maintenance after approval. CoreMed provides CMC regulatory consultancy and prepares CMC dossier taking into consideration this point.
CoreMed has expertise not only in chemically synthesized small molecules, but also in biologics such as recombinant antibody and regenerative medicinal products.CoreMed’s CMC team helps clients
- ・Gap analysis of CMC documents
- ・Solutions to the gaps
- ・Preparer CMC briefing documents for consultation meetings with the PMDA
- ・Responses to inquiries from regulatory authorities
- ・GMP compliance inspection
- ・Japanese DMF
- ・Foreign Manufacturer Accreditation (FMA)
- ・Japanese Accepted Name (JAN)
- ・Due diligence activities of licensing and approval transfer
- ・Regulatory submission dossier (CTD/eCTD, Clinical Trial Notification (CTN), ODD)
- ・Partial Change Approval Application/Minor Change Notifications
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