Coremed

Coremed Co., Ltd. is a leading Japanese regulatory affairs and clinical development consultancy that facilitates the entry of international pharmaceutical and biotechnology companies into the Japanese market. Founded in 2000 and headquartered in Tokyo, the company provides specialized services including In-Country Clinical Caretaker (ICCC) representation, Pharmaceuticals and Medical Devices Agency (PMDA) consultation management, and clinical trial operations. Coremed's expertise is particularly vital for navigating Japan's unique regulatory landscape, including the management of bridging studies and ethnic factor requirements. The firm supports a wide range of therapeutic developments, with significant experience in oncology, orphan drugs, and regenerative medicine. By acting as a strategic liaison between global sponsors and Japanese authorities, Coremed streamlines the path from initial clinical trial notification to final marketing authorization.