As an important link of pharmaceutical research and a prerequisite for the registration of a product for marketing approval, Process characterization (PC) and process validation (PV) studies aim to ensure that the drug manufacturing process is always under control and can consistently produce products that meets quality requirements.
Process validation and continuous lifecycle management are based on the internationally accepted "Quality by Design" (QbD) concept and the rigorous DoE design test method. The protocol is designed in strict accordance with the regulatory requirements (NMPA/FDA/EMA) of the region where the investigational drug need to obtain the approval and marketing authorization.
Customized solutions can be made for clients with specific needs and at specific stages of their projects. Flexible scheduling and multiple parallel lines can be guaranteed to shorten the project cycle.
The advanced process, strong production team, and rich practical experience in PC/PV programs ensure smooth project delivery.
As an important link of pharmaceutical research and a prerequisite for the registration of a product for marketing approval, Process characterization (PC) and process validation (PV) studies aim to ensure that the drug manufacturing process is always under control and can consistently produce products that meets quality requirements.
Process validation and continuous lifecycle management are based on the internationally accepted "Quality by Design" (QbD) concept and the rigorous DoE design test method. The protocol is designed in strict accordance with the regulatory requirements (NMPA/FDA/EMA) of the region where the investigational drug need to obtain the approval and marketing authorization.
Customized solutions can be made for clients with specific needs and at specific stages of their projects. Flexible scheduling and multiple parallel lines can be guaranteed to shorten the project cycle.
The advanced process, strong production team, and rich practical experience in PC/PV programs ensure smooth project delivery.
