Professional Documentation Support

Our Regulatory Affairs consultants and Medical Writing team have established good records in documents preparation. We can assist in making inquiries to regulatory authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japan Ministry of Health, Labour and Welfare (MHLW), as well as in preparing materials for submission and approval and preparing responses to inquiries from authorities.

Our Edge in Regulatory Submissions and Correspondence

Established good reputation in documents preparation

  • We can draft study-related documents of high quality, such as CSRs and CTDs, in English and Japanese. We can meet strict timelines by working collaboratively with >70 internal medical writers, using external resources when needed. Our RA experts can draft and support filings of marketing approval applications, followed by drafting their Q&As with competent authorities to obtain their approvals.


Clinical Trial Notification (CTN) Marketing Authorization Application
Preparation of CTN and documents Preparation of CTD (eCTD)
Response to PMDA inquiries Response to PMDA inquiries
Revision of CTN and documents Masking of CTD and Product Review Report
Amendment to Clinical Trial Protocol Pre-submission PMDA meeting
Notification of Completion/Discontinuation
Support obtaining business licenses for Japan Designation Application/Registration
Marketing License Orphan Drug or Sakigake Designation
Manufacturing License JAN (Japan Accepted Name) Registration
Foreign Manufacturer’s Accreditation Drug Master File Registration
CMC Consulting

CMC Consulting


Regulatory Affairs

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