For many companies conducting pre-clinical and clinical development programs it is often necessary, and usually cost-effective, to outsource manufacturing of the study drug to a Contract Manufacturing Organisation (CMO).
This outsourcing gives rise to a number of commercial and legal issues which need to be carefully managed to limit the risks to the company concerned. In this article we examine a number of the risks, the problems which can arise and the strategies which can be employed to minimise the potential exposure.
A legal toolkit for life sciences companies and their investors providing access to information on:
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