Traditional Chinese medicine is perhaps the oldest formalized pharmaceutical system practiced in the world today. With such a long and established tradition, it is hardly a surprise that the relatively recent incorporation of Western medicines into this ancient apothecary system has not been without its unique characteristics. The Chinese regulatory authorities, referred to in western script as the Chinese FDA (cFDA), have established a comprehensive system to ensure the safe production, manufacture, distribution, and consumption of pharmaceutically active drug substances. Due to the limited organizational size of Western companies, rapid growth in China and the evolving nature of compliance legislation, Western companies need in-country guidance to optimize approval and commercialization of their product portfolio offering in China.
That’s why PaizaBio assistance in navigating Chinese pharmaceutical and other business-related regulations is so critical in easing market entry for U.S. and European pharmaceutical companies seeking to enter the Chinese aseptic market. We have held a leadership position in contract fill-and-finish for aseptic parenterals in China for two decades. No one understands manufacturing regulatory requirements like PaizaBio. And that includes those of China, the United States, Europe, and Latin Americaas well as other international regulatory agencies.
Our regulatory support services include:
- Thorough evaluation of products presented by clients to ensure new products and processes meet defined regulatory requirements in China
- Consultation on how best to achieve compliance
- Liaison for all communications with regulatory agencies
- Coordinates assembly of client product and process related documentation suitable for the client’s preparation of regulatory submissions
- Coordination of regulatory agency inspections
- Formal client notification system of any changes in our facility, utilities, and processes as well as to notify clients of new products being manufactured