How does CoreMed prepare the CTD and eCTD? For the J-NDA?
CoreMed evaluates and prepares a fully integrated CTD and electric CTD (eCTD) from Module 1 to 5 in compliance with ICH and/or regulatory guidelines of each competent authorities. The Japanese authorities does not accept CTDs which is simply just translated US/EU CTDs into Japanese. CoreMed prepares J-CTD according to the Japanese requirement after conducting the gap analysis.
Can CoreMed be an In-Country Caretaker (ICC) for Clinical Trials on behalf of NON-Japanese sponsors in Japan?
Liaison with the Japanese regulatory authorities as an ICC for opening and maintaining CTN (Clinical Trial Notification) on behalf of NON-Japanese companies in compliance with ICH and J-GCP. CoreMed can also evaluate, select and manage CROs for Sponsor’s clinical trials.
Can CoreMed do the regulatory procedure for antibody drugs and biologics in Japan?
Liaison with the Japanese regulatory authorities as an ICC for opening and maintaining CTN (Clinical Trial Notification) on behalf of NON-Japanese companies in compliance with ICH and J-GCP. CoreMed can also evaluate, select and manage CROs for Sponsor’s clinical trials.
Can CoreMed do the regulatory procedure for antibody drugs and biologics in Japan?
CoreMed, with extensive experience in handling biologics such as vaccines and biotechnology products, prepares, conducts gap analysis on and reviews regulatory documents for clinical trials and product registration.
Can CoreMed assist PMDA consultations and address enquires from PMDA after NDA submission?
CoreMed supports our clients to establish and evaluate strategy/tactics, reviews and prepares briefing documents. Our extensive experience leads clients to successful outcomes.
Can CoreMed support an Orphan Drug Designation application?
Can CoreMed support and apply the Accreditation of Foreign Manufactures?
Japan has its own requirements and procedures for designation of an Orphan Drug Designation (OD).
CoreMed, well aquainted with OD processes, prepares and submits OD applications and guides clients to obtain OD.
Can CoreMed prepare and apply for the new Drug Master File (DMF) registration to with the PMDA?
CoreMed prepares and submits (Drug) Master File (MF) application for APIs for non-Japanese manufacturers as an In-country Caretaker.
CoreMed has extensive experience in MF registration.
Tell what is the Legal Representative?
CoreMed provides LR services in collaboration with Verius Limted (UK) in Europe.

Verius, contemplated and regulated by EC Directive, plays the role of a sponsor representative for European clinical trials including notification of clinical trials, signing regulatory documents for clinical trials, reporting SUSARs, submitting annual safety reports, and co-ordination with local authorities for investigator on-site inspections.
Tell what is the “Quality Person (QP)” and its role?
CoreMed provides a QP services in collaboration with Biotec Services International (UK). A QP is required to release supplies of IMPs that have been manufactured outside the EU for use in European clinical studies. As required, our QPs will conduct audits of manufacturing facilities & ensure that each manufacturing batch has been manufactured in accordance with cGMP guidelines.
Tell what is a “US (United States) agent” and its role?
The FDA requests a non-US sponsor to appoint a US agent when the sponsor conducts clinical trials ,imports investigational drugs, and registers FDA’s regulated products in the US. The US agent also acts as a communication link between the FDA and the foreign company for communications. CoreMed America, LLC is experienced in providing such services as the US Agent for both drugs and medical devices to non-US based companies.

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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