Service Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services for medical products in Japan.

Service

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.

Regulatory affairs

Consulting for gap analysis for Japanese requirements, application dossier preparation, reimbursement

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Local product development

Services related to clinical studies for product registration in Japan

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DMAH services

We provide comprehensive regulatory assistance as a DMAH for foreign drug, medical device and IVD manufacturers to enter into Japanese market.

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ICC services

Comprehensive regulatory related assistance for DMF registration for foreign manufacturers of APIs, and In-Country Caretaker services

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