Providing technical transfer and validation of a commercial manufacturing process for tablet formulations

Challenge

A US biotech company had a small molecule anti-cancer drug on the market in the US and other products in development. The company needed CMC consulting expertise in order to access European opportunities.

Solution

We provided a European CMC consultant to support the whole process of European transfer and validation. This included:

  • overseeing technical transfer of the manufacturing process from the US to selected European contract manufacturers, and validation to meet both European and FDA guidelines
  • looking after the technical transfer and validation of packaging activities for the product
  • reviewing and approving the batch documentation and reports generated as part of the manufacturing and packaging activities
  • providing similar support for the transfer of a second product from the US to a second manufacturing site in Europe
  • general CMC consultancy on a wide range of other areas connected with the client’s various development programmes
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