北京惠康世纪生物技术顾问

Beijing Huikang Shiji Biotechnology Consultant is a professional regulatory affairs and clinical research organization (CRO) based in Beijing, China. Founded in 2001, the company specializes in providing comprehensive registration and consulting services for medical devices, in vitro diagnostics (IVDs), and pharmaceutical products. Their core expertise lies in navigating the complex requirements of the National Medical Products Administration (NMPA) for both domestic and international manufacturers. The firm offers a wide range of services, including regulatory strategy development, clinical trial design and management, and technical documentation preparation. By facilitating the market entry of innovative healthcare technologies, Huikang Shiji serves as a critical bridge between global life science companies and the Chinese market.