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