Tongze Hexin (Beijing) Medical Technology Co., Ltd.

Tongze Hexin is a specialized Contract Research Organization (CRO) and regulatory consulting firm based in Beijing, China. The company focuses on the In Vitro Diagnostics (IVD) industry, providing comprehensive solutions including regulatory strategy, clinical trial management, quality management system (QMS) consulting, and innovation registration services for reagents, instruments, and software. They assist both domestic and international clients in navigating NMPA, FDA, CE, and WHO approval pathways. The company is known for its expertise in guiding innovative medical devices through special review procedures and maintaining high-quality standards for clinical and regulatory compliance.