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.

Services

Clinical Trial Notification (CTN)Marketing Authorization Application
Preparation of CTN and documentsPreparation of CTD (eCTD)
Response to PMDA inquiriesResponse to PMDA inquiries
Revision of CTN and documentsMasking of CTD and Product Review Report
Amendment to Clinical Trial ProtocolPre-submission PMDA meeting
Notification of Completion/Discontinuation
Support obtaining business licenses for JapanDesignation Application/Registration
Marketing LicenseOrphan Drug or Sakigake Designation
Manufacturing LicenseJAN (Japan Accepted Name) Registration
Foreign Manufacturer’s AccreditationDrug Master File Registration

CMC Consulting

Regulatory Affairs