Regulatory Affairs

At WuXi AppTec, we continuously monitor the ever-changing regulatory environment in China. By keeping up to date with these evolutions, we can help you grasp new opportunities to speed up product approval and overcome any regulatory and technical hurdles that may stand in the way of product development and approval in China.

Our C&R teams assist clients with clinical trial application, registration and marketing authorization of pharmaceuticals, biologics, drug device, and other healthcare products. We have an excellent track record in the registration advisory field with thorough understanding of the regulations and requirements of national and international agencies from yearsof practical experience. The registry services are conducted with effective project management, while maintaining strict confidentiality of technical data and information.

We can assist you with all your regulatory requirements, and ensure that your dossiers are prepared correctly and on time, so your drugs, biologics, medical devices, and healthcare products move though the regulatory process as smoothly and quickly as possible.

By providing expert regulatory strategy, consultation and execution, WuXi AppTec helps clients stay on the path to early approval in China.