Clinical Development

Clinical Development

CoreMed establishes most efficient clinical development strategy and minimum clinical data package for marketing approval.

To reduce the time to NDA submission and minimize risks, it is important to have a well-defined and designed clinical development strategy and to be familiar with the regulatory requirements in each region. CoreMed understands regulatory and medical environments as well as regulations, guidelines and requirements, and advises how to utilize non-Japanese clinical data.

CoreMed’s clinical strategy planning team helps clients

  • Clinical gap analysis
  • Clinical development strategy from early development phase
  • PMDA consultation meetings
  • Clinical study protocols
  • Selection of CROs
  • CTN dossier
  • GCP compliance

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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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