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Regulatory Affairs


Regulatory Affairs

WuXi AppTec has a group of senior research scientists and senior regulatory policy experts based in China, United States and Europe. Our scientists have wealthy industry resources and rich pharmaceutical/biotech research background.  We are not only knowledgeable of relevant government policies regulations and rules for how to implement in the product registration process, but lively communicating with agencies and reviewers from a technical and strategic point of view to ensure the timely feedback to drug developers. WuXi’s regulatory strategy is to expedite the drug development to regulatory approval. With multidisciplinaire in-house development expertise and multi-cultural company value, WuXi’s regulatory service is a regional hub in China bridging China/Asia and global drug development to expand sponsor’s market reach.

 

Our services includes:

US FDA:

We can be help in the following directions for you:

  • Regulatory consultation, project feasibility assessment, product registration strategy and planning 
  • IND dossier composition
  • Pre-IND meetings 
  • eCTD submission
  • Annual reports and subsequent supplement submissions

 

China CFDA: 

We can help you in the following ways:

  • Registration strategy
  • Gap analysis based on available dossier information 
  • Dossier prep consultation and composition 
  • CFDA IND application submission 
  • CDE review progress follow-ups, amendment submission 
  • NIFDC testing progress follow-ups
  • Arrange and guiding pre-review / consultation meetings between developers with CDE/CFDA 
  • Other assistance in product registration