GRP Japan

Global Regulatory Partners (GRP) Japan is a specialized contract research organization (CRO) and regulatory affairs consultancy providing comprehensive market access solutions for the Japanese healthcare market. The company assists pharmaceutical, biotechnology, and medical device manufacturers in navigating the complex regulatory requirements of the Pharmaceuticals and Medical Devices Agency (PMDA). GRP Japan offers a suite of services including In-Country Caretaker (ICC) representation, regulatory submissions, clinical trial management, and quality management system (QMS) compliance. In 2023, the company was acquired by Lumanity, a global health science company, to enhance its global regulatory and commercialization capabilities. Their expertise spans various product types, including small molecules, biologics, and complex medical devices. GRP Japan is recognized for its ability to bridge the gap between international manufacturers and the Japanese healthcare market, ensuring compliance with local standards.