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.
|
