PMDA, FDA and/or EMA

PMDA, FDA and/or EMA

CoreMed establishes strategies and tactics for successful consultation meetings with the PMDA and organize meetings with the PMDA to ensure successful development and marketing approval in Japan. CoreMed covers not only clinical but also CMC and nonclinical consultation meetings.

CoreMed evaluates available data and prepared briefing documents for consultation meetings. Also, CoreMed advises clients on what should be prepared and what should be discussed with the PMDA.

CoreMed organize the PMDA meeting on behalf of our clients and liaise with the PMDA including responses to inquiries from the PMDA.

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Business Alliances

  • Japan | eCTD | Digital Media Systems, Co. Ltd.
  • 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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