Consulting for gap analysis for Japanese requirements, application dossier preparation, reimbursement
We provide strategic and operational services to obtain regulatory approvals for our clients’ medical products in Japan.
Over the past thirty years, our staff have acquired expertise in product development and registration of pharmaceuticals, biologics, medical devices and diagnostics, both in Japan and North America.
At Cobridge we combine our knowledge of regulatory affairs with scientific knowledge and experience to provide our clients with preclinical and clinical project management; chemistry, manufacturing and controls regulatory document preparation; regulatory consulting and dossier preparation; industry training; and other drug development consulting services for their products.
Services related to clinical studies for product registration in Japan
We provide comprehensive regulatory assistance as a DMAH for foreign drug, medical device and IVD manufacturers to enter into Japanese market.