Pharmaceutical Regulatory Services
SCAS provides regulatory services such as preparation of applications and notifications and advice on application procedures. Please contact us to know more about our services.
- Support for the preparation of Common Technical Document (CTD)
- Preparation of master file registration application documents and the final application
- Application for accreditation of foreign manufacturers
- Application for obtaining manufacturer codes for foreign manufacturers and manufacturing sites
- Application for Good Manufacturing Practice (GMP) compliance inspection
- Taking on the role of in-country caretaker for drug substances, etc.
- Response to inquiries from review authorities
- Preparation of other applications and notifications
- Consultation on application
Support for master file registration application
The Master File (MF) system for drug substances, etc., which is intended for the protection of manufacturers' intellectual properties and for the smooth operation of regulatory marketing approval, was introduced by the revised Pharmaceutical Affaires Law enforced on April 4, 2005.
In this system, a foreign manufacturing company can also apply for MF registration. However, works concerning the MF registration must be performed by an in-country caretaker who has a Japanese address; further, it is necessary to obtain accreditation of the foreign manufacturer and manufacturer codes for the foreign manufacturer and the manufacturing site. In addition, MF registration application form, related documents, and Common Technical Document (CTD) Module 2, which is required at the review of the drug product for quoting the registered MF, must be written in Japanese. Because the PMDA may reject documents that are simply translated into Japanese, the documents must be prepared according to the Japanese guidelines and Japanese Pharmacopoeia, etc.
Our company SCAS prepares documents required for MF registration by using the experience and knowledge acquired in many quality tests and specifications. Further, we undertake various works about MF registration application.
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