Drug development and design
We carry out comprehensive drug quality and safety risk assessment in terms of drug characteristics, toxicology research and clinical research, determine key quality attributes and key process parameters of products, establish process design space, process control indexes and final product quality standards, and lay an excellent quality foundation through rigorous R&D design.
Drug technology transfer
We transfer drug knowledge, technology and related products and processes from the drug development stage to the production stage, while continuously identifying and evaluating improvement opportunities, optimizing process technologies or routes, and strictly implementing process validation to ensure safe, stable, and reliable drug production process.
Commercial production of drugs
The company establishes a scientific and comprehensive quality management system, use FMECA, FTA and other risk management tools to conduct risk assessment on drug production and quality control process from five aspects of human, machine, material, method and environment, develop corrective and preventive measures, regularly review the controllability of risks, continuously improve the quality management system, and control the quality risks of drug production, in order to ensure that drugs are safe, effective and controllable.
Market tracking and monitoring
We strictly perform our responsibility for safety, establish an effective pharmacovigilance management system, develop post-marketing risk management plans for drugs, take the initiative to carry out post-marketing research on drugs, further confirm the safety, efficacy and quality controllability of drugs, minimize drug safety risks, protect and promote public health, and realize the whole life cycle management of drugs.