Success Story - To Japanese Market with CoreMed

Company B, a non-Japanese company, has no presence in Japan. CoreMed worked together on a pre-Phase 1 PMDA consultation meeting. Based on the successful meeting outcome and Phase 1 results, Company B has found a Japanese partner and has been collaborating with them towards the J-NDA.

Regulatory Assessment
CoreMed evaluated their CMC, nonclinical and clinical data, and established clinical development strategy for Japan.

PMDA consultation meeting
Based on the regulatory assessment, CoreMed organized a pre-Phase 1 consultation meeting with the PMDA on behalf of Company B. The main discussion points were:
  • Sufficiency of nonclinical study data to start clinical study in Japan
  • Phase 1 protocol
  • Overall development plan for the J-NDA

The outcome of the meeting was very positive, and Company B started Phase 1 in Japan appointing an In-Country Clinical Trial Caretaker (ICCTC) who run the study. CoreMed helped them find an ICCTC and prepare Clinical Trial Notification. From time to time, CoreMed advised Company B.

Finding a Japanese partner
Based on the successful outcome and Phase 1 data, Company B has found a Japanese partner who will be a future MAH.

Further development towards the J-NDA
Company B and the Japanese partner has been collaborating towards the J-NDA. CoreMed still serves as regulatory consultant for Company B. In addition, CoreMed has been helping some of tasks of Company B.

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
    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