Regulatory Affairs

Regulatory Affairs

CoreMed is a major provider of strategic regulatory consultancy in Japan. We have primarily focused on regulatory affairs since established in 1998. CoreMed has been providing practical and strategic supports in designing regulatory strategies, analyzing the gap between data and regulatory requirements and preparing all types of regulatory submission dossier as well as marketing approval applications with watching legislations and pharmaceutical affairs laws (PMD-Act) closely. We have experience not only in chemically synthesized small molecules but also in biopharmaceuticals including regenerative medicinal products such as cell therapy products.

CoreMed covers all stages of development for all types of products and encompasses CMC, nonclinical and clinical aspects.

CoreMed’s regulatory team helps clients

  • Strategic regulatory development plan integrated with MHLW & PMDA/Japan, FDA and EMA requirements
  • PMDA consultation meetings and other guidance meetings with other regulatory authorities
  • JNDA filing strategy
  • Orphan Drug Designation (ODD)
  • Liaison between regulatory agencies and clients
  • Up-to-date information of pharmaceutical and medical device regulations and guidelines/guidance in Japan, US, and Europe
  • R&D and Regulatory Due Diligence
  • Gap analysis and Assessment of data
  • Feasibility study
  • GxP compliance inspection
  • Regulatory submission dossier (CTD/eCTD, DMF, FMA, CTN etc.)
  • Responses to inquiries from the authorities
  • In-Country Caretaker for Master File (J-DMF)
  • Agent for Foreign Manufacturer Accreditation (FMA)


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
    (FAX) +81-(0)6-6221-1357

  • Tokyo office
    13F Pacific Century Place Marunouchi, 1-11-1, Marunouchi, Chuo-ku, Tokyo 100-6213, Japan
    (TEL) +81-(0)3-6860-8642
    (FAX) +81-(0)3-6860-8201