In accordance with the NMPA, FDA and EMA regulations and guidelines, as well as pharmaceutical quality system on lifecycle management of ICHQ8-Q10, a quality management system has been established and approved by the authority. The production workshops for monoclonal antibody and chemical oral preparations workshop have passed the national drug registration and GMP inspection. TOT BIOPHARM has extensive experience in receiving the authority inspection for drug registration, ensuring high quality of the product from R&D to commercial manufacturing.