Beijing Tongze Medical Technology Co.,Ltd is a regulatory consulting and CRO (Contract Research Organization) service organization focusing on the field of in vitro diagnostic reagents, and is committed to providing complete solutions in the fields of global regulatory consulting, clinical trial management, quality management system consulting, regulations and quality management system training. To provide domestic and foreign customers with high efficiency, high quality professional services.
Professional: Our business is specialized in the field of in vitro diagnosis, participate in the enterprise research and development stage, GMP plant construction stage to registration and clinical trial stage to provide one-stop consulting and services, to help enterprises establish a standardized and standardized work system earlier;
Experience: We have more than 400 practical implementation experiences of projects, including in vitro diagnostic instruments, biochemical, immune, pathological, blood, microbial, molecular diagnostic reagents, etc. Rich experience is the basis for providing good service to enterprises, and it is also the reason for you to choose to establish a cooperative relationship with us.
Depth: Most of the projects provided are for class III high-risk products as well as the first innovative products in China, and we focus on tumor, infectious disease and genetic products in the fields of traditional molecular diagnosis and second-generation sequencing. This enables us to have a deep understanding of the technical research of products, the interpretation of national regulations and policies and the development trend. In the face of complex product technology principles, product innovation has no precedent experience in the country, regulations and policies are unknown, the direction is unknown, through our systematic research and analysis to help enterprises point out the direction, seizing the decisive opportunity.