Cobridge Co.,Ltd.

medical devices

About

Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services for medical products in Japan. We 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). Through a wide range of services, including regulatory affairs, clinical studies, Designated Marketing Authorization Holder (DMAH), preparation of drug master files (DMFs) and acting as their In-Country Caretaker (ICC), we supports clients entering the Japanese market with their medical products including pharmaceuticals and medical devices.

Technologies

Google Plus Google Tag Manager Google AdWords Conversion Google Analytics Google AdSense Apache Google Font API WordPress.org IoT AI

Keywords

api ivd regulatory affairs clinical studies preparation of drug master files medical device dmah service medical equipment manufacturing quality control (qms) clinical consultation support regulatory consultation meetings product registration global client support regulatory dossier preparation foreign medical device approval consulting product development support pmda communication cost-effective regulatory pathway medical device market access product approval application japan regulatory affairs regulatory pathway regulatory change management medical device registration product lifecycle management healthcare pre-market approval international regulatory support overseas manufacturer support

Location

Chiyoda, Tokyo, Japan

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