Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

WuXi Biologics provides expert regulatory strategy, consultation and execution services. We have established a team of regulatory experts with years of practical experience in the registration advisory field and thorough knowledge of the regulations and requirements of national and international agencies.  Services include:

  • Regulatory CMC guidance in compliance with global standards according to ICH, CFDA, U.S. FDA, and EMA guidelines and other government regulations
  • Assistance with worldwide regulatory submissions including clinical trial application, registration and marketing authorization applications
  • Registry services utilizing effective project management to ensure that your dossiers are prepared correctly and timely while maintaining strict confidentiality of technical data and information

In addition, 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 expedite product approval and overcome any regulatory and technical hurdles that may stand in the way of product development and approval in China.  Let WuXi Biologics be your partner and gateway to the China healthcare market.

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