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Case Studies

Complex Outsourcing Contract

Challenge:

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.


Solution:

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.

Benefit:

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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