Regulatory Document Preparation

Regulatory Document Preparation

CoreMed evaluates available data (gap analysis) and prepare regulatory submission dossier such as CTD/eCTD Module 1 thought Module 5, Orphan Drug Designation, DMF, CTN.

Translation of overseas documents into Japanese is not always appropriate for Japanese submission. CoreMed prepares the dossier in appropriate Japanese language and Japanese writing style based on the available documents.

CoreMed provides comprehensive solutions, called “Medical Writing / eCTD Compiling Collaboration Services” collaborating with Digital Media Systems Co., Ltd who is a Japanese eCTD leading company and has significant expertise in eCTD which complies with Japan specific eCTD requirements. CoreMed writes CTD and prepare eCTD simultaneously from the beginning and completes the NDA application dossier seamlessly.

CoreMed will evaluate and prepare

  • CTD/eCTD (CTD m1, m2.3, m3, m2.4/2.6, m2.5/2.7 and eCTD)
  • Maintenance (Partial Change Approval Application/Minor Change Notifications)
  • Briefing documents for consultation/scientific advice/guidance meetings
  • Orphan Drug Designation application
  • DMF
  • Foreign Manufactured Accreditation
  • GMP compliance inspection
  • Japanese Accepted Name (JAN) application dossier
  • CTN
  • Investigator brochures (IB)
  • Study protocols
  • Clinical study reports (CSR)
  • STED


Business Alliances

  • Japan | eCTD | Digital Media Systems, Co. Ltd.
  • FDA | GxP Compliance | Polaris Compliance Consultants, Inc.
  • FDA |Global Regulatory Consulting | B&H Consulting Services, Inc.
  • 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