COBRIDGE

Cobridge is a regulatory affairs consulting firm and supports foreign medical device manufacturers for their medical device registration in Japan... Cobridge offers a comprehensive list of regulatory services, in formulating best cost-effective regulatory strategies, in preparing application documents, and in communicating with the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). We arrange and conduct pre-clinical, clinical, and pre-approval consultation meetings with the PMDA on behalf of or with our overseas clients. For the oversea manufacturers of medical devices, we prepare and file new product approval applications (shonin-shinseisho and STED) or third-party certification applications (ninsho-shinseisho) by acting as the Designated Marketing Authorization Holder (DMAH) throughout the process from application to post-marketing stage. For API manufacturers, we handle preparation and filing of master files (DMFs) and act as..

Also known as: Cobridge Co.,Ltd.

Primary location: Tokyo Japan