About CoreMed

CoreMed is a Japan based Contract Regulatory and Strategy Development Consulting Firm specifically providing Non-Japanese pharmaceutical, bio-pharmaceutical and medical device companies with state-of-the-art strategic regulatory consulting services.

Company brochure (PDF) is AVAILABLE.

CoreMed

CoreMed Corporation, a Strategic Regulatory and Drug Development Consulting Firm, is founded in March 1998 in Osaka, Japan. CoreMed has focused on regulatory affairs primarily for more than 17 years since its establishment. We have been providing practical and strategic supports for designing regulatory/development strategies, analyzing the gap between data and regulatory requirements. CoreMed covers all stages of development for pharmaceuticals, biopharmaceuticals and regenerative medicinal products, and encompasses CMC, nonclinical, clinical aspects. We always watch pharmaceutical legislations and changes in regulatory environment closely. CoreMed think globally with understanding local requirements.

Our services are:

  • Regulatory and development strategy
  • Consultation meetings with the PMDA
  • NDA submission
  • Orphan drug/device designation application
  • Application for clinical trials
  • Responses to inquiries from the authorities
  • Medical/Technical writing (CTD/eCTD, CSR, IB, Study Protocol)
  • Master File Registration
  • Foreign Manufacturer Accreditation
  • Regulatory intelligence
  • National Health Insurance Pricing
  • Project management
  • Support for legal proceedings (e.g. Expert witness)

CoreMed

CoreMed dedicates ourselves to helping pharmaceutical companies develop their products efficiently and expeditiously with navigating them through the regulatory approval process in Japan. CoreMed’s experts in Regulatory Affairs, CMC, Nonclinical and Clinical are passionately supporting pharmaceutical companies to bring their products to launch by designing the most appropriate development strategy.

Sincerely, Masami Tamura President and CEO

Company Information

Company name CoreMed Corporation
Foundation March 16, 1998
Our main services
  • Design, execution and gap analysis of regulatory strategy
  • Design and planning, evaluation, management, support of clinical development
  • Design, gap analysis of CMC documents/programs
  • Design and planning, strategic development, management of nonclinical studies
  • Writing, preparation, compilation and submission of regulatory applications including CTD/eCTD, Orphan Drug/Device Applications, DMF, FMA CTNs,
  • Preparation and arrangement of Consultation Meetings with PMDA
Headquarters

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Tsunenari Bldg., 2-1-21, Kitahama, Chuo-ku, Osaka 541-0041, Japan (TEL)+81-(0)6-6221-1352 (FAX)+81-(0)6-6221-1357

Tokyo office

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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

Management Masami Tamura, Pharmacist, President and CEO, Co-founder
Divisions Regulatory Affairs, CMC, Nonclinical Development, Clinical Development, Development Strategy
Senior Regulatory Advisor Toshiki Hirai, M. Pharm (Former Director of Evaluation and Licensing Division of Pharmaceutical and Food Safety Bureau, MHW)
Medical Advisors Tohru Masaoka, MD (Former Head of Osaka Medical Center for Cancer and Cardiovascular Diseases)

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

    map
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