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 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 |
