Registration of Drug Master File (DMF) in Japan

In Japan, Drug Mater File (DMF), known as Master File (MF), is a system that was introduced by Pharmaceuticals and Medical Devices Agency (PMDA) to allow Japanese and foreign manufacturers (MF Holders) of drug substances, intermediates, excipients, raw materials, and packaging materials (“Products”) to voluntarily register confidential information related to the manufacturing and control of their products in Japan.

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About Global Regulatory Partners Inc:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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