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Case Studies

Complex Outsourcing Contract


Our client needed to manufacture drug product for early clinical trials but had no cGMP facilities for in-house production and needed external expertise in outsourcing to review the contract terms and evaluate the suitability of the facility.


One of our experts provided a rapid review of the contract and facility identifying key operational, compliance and regulatory issues of potential concern to regulatory authorities.


Our client was able to evaluate and pursue an alternative approach avoiding the potential for considerable regulatory issues later in development.

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