Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services for medical products in Japan.
The company was founded in 1999. It has its offices in central Tokyo, in the Chiyoda district, near the legislative and other governmental buildings.
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 CTD or 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. We also prepare drug pricing applications, medical device pricing applications, and reimbursement applications for procedural fees for submission to the Economic Affairs Division, Health Policy Bureau, MHLW. For API manufacturers, we handle preparation and filing of master files (DMFs) and act as their in-country caretaker (ICC).
The past thirty years, our scientific staff have acquired expertise in product development and registration of medical devices and diagnostics in a variety of manufacturing firms as well as in contract research organizations (CRO) both in Japan and the United States. From the company’s founding as the first specialized regulatory affairs consulting firm in Japan, we have covered a variety of therapeutic areas, from oncology, cardio- and neurovascular, wound therapy, and gastroenterology areas, to gene therapy for rare genetic diseases. This has been made possible by the professional strengths and experience of our staff, who uniformly have a strong scientific background in the basic medical sciences.
All of our technical staff are native-Japanese speakers who can interpret the often difficult-to-apprehend meaning of Japanese regulatory pronouncements. Nevertheless, the staff’s strengths include facility in English and, unlike with other consulting firms where the staff with good English skills are typically not graduates with technical degrees, our staff’s ability to handle technical documentation in English is based upon a scientific background which lends the ability to interpret, not only translate. This combination of technical background and English language skills lays the groundwork for not only understanding the technical documents that are the foundation of regulatory dossiers, but also for personal interaction that characterizes telephone and video conferences with our overseas clients during the progress of their projects. Each of our professional staff members is with the company on a full-time, permanent basis, and the technical core team has been with the company on this basis since its founding. Unlike a virtual firm with minimum full-time permanent staff, Cobridge takes care of all of its projects by its in-house staff, and because of this low turnover clients can also expect a long-term, stable relationship with the staff handling their projects.