Chemical, Manufacturing & Controls

Chemical, Manufacturing & Controls

CoreMed manages all of regulatory aspects of chemistry, manufacturing and controls (CMC), and creates and implements strategies to support the entire development processes from drug discovery to regulatory approval. CoreMed is familiar with Japan specific CMC requirements and ensure successful marketing approval. CMC documents is directly related to the “Certificate of Approval” which is binding and subject to maintenance after approval. CoreMed provides CMC regulatory consultancy and prepare 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 and its tripartite network help client’s CMC team

  • 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
  • Japanese Accepted Name (JAN)
  • Due diligence activities of licensing and approval transfer
  • Regulatory submission dossier (CTD/eCTD, CTN, ODD)
  • Partial Change Approval Application/Minor Change Notifications

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Business Alliances

  • Japan | eCTD | Digital Media Systems, Co. Ltd.
  • FDA | GxP Compliance | Polaris Compliance Consultants, Inc.
  • FDA |Global Regulatory Consulting | B&H Consulting Services, Inc.
  • EU | Global Regulatory Consulting | Dr. Regenolod GmbH
  • SFL Regulatory Affairs & Scientific Communication Ltd.
  • Headquarters
    Tsunenari Bldg., 2-1-21, Kitahama, Chuo-ku, Osaka 541-0041, Japan
    (TEL)+81-(0)6-6221-1352
    (FAX) +81-(0)6-6221-1357

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  • Tokyo office
    KN Nihonbashi Bldg., 4-8-17, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan
    (TEL) +81-(0)3-5205-2757
    (FAX) +81-(0)3-5205-2758

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