Regulatory

What else we can offer you

Dastech’s regulatory team, both in the US and China, performs a number of functions: 

  • Provide customers with the latest documentation to enable them to meet current governmental requirements whether in the US or elsewhere. 
  • Act as the US Agent to the FDA for a number of our suppliers.
  • Maintain membership on the Bulk Pharmaceutical Task Force who negotiates with FDA concerning quality issues and development and improvements to GDUFA.
  • Work with our suppliers to make sure that they are fully compliant with international regulations.
  • Assist our suppliers with the preparation for regulatory audits.
  • Coordinate and accompany customers for supplier audits.


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