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Case Studies

An Audit that Accomplished Quality, Regulatory AND Team-Building Objectives

Challenge:

Our US client was new to outsourcing API synthesis and had selected an outsourcing partner in Europe with expertise in the chemistry required but limited experience in cGMP manufacture.


Solution:

An auditing team including regulatory, quality and operational expertise enabled a fast response in support of tight timelines and identified key issues to be addressed. The combined skills provided essential support to the contractor to better understand and respond to our client's needs as well as assurance of cGMP compliance.

Benefit:

Our client benefited from improved performance of their contractor as a result of our strategic and operational input.


Click here to see information on the Advisors Team that helped this client.