Japan API Drug Master File Submission

Manufacturers of Active Pharmaceutical Ingredients (APIs) need local professional support to file a Drug Master File (DMF) in Japan.

Japan has an API Drug Master File (DMF) system for drug substances which allows foreign manufacturers to register their data including quality systems, manufacturing methods, specifications etc. of their APIs directly to the PMDA. This helps keep your confidential information, confidential.

The English version of a DMF needs to be rewritten according to Japanese regulation and translated into Japanese before it can be submitted to the PMDA. If this work is not done correctly, the PMDA may send  several inquiries and requests for supplemental documents – a process that could cost a lot of time and money, not to mention serious delays for customers in Japan.

Pacific Bridge Medical can handle the entire DMF filing process. We have a team of experts that focus on DMF filing in Japan. Our team has the knowledge and experience to know how to get the job done both quickly and meticulously.

We have decades of experience with working with the PMDA. If the PMDA has any inquiries about your API in Japan, we will immediately translate the inquiry for you and also provide our expert recommendations on how to respond. After obtaining your approval, we will translate your responses to Japanese and work with PMDA until their inquiries are satisfied.

Pacific Bridge Medical can provide you with guidance to make sure your API complies with the latest Japanese Pharmacopeia (JP) standards.

Contact us today for a free 15 minute consultation to discuss your specific case.

 

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