A start-up, preclinical/nonclinical CRO, servicing the biotechnology and pharmaceutical industries.
Our client’s customers required their nonclinical CRO to have a full Quality Management System, one that could be audited against and that would enable our client to fulfill the necessary requirements to be GLP compliant.
Our client did not have the required expertise in-house.
MLC was brought in to help support the transition from R&D nonclinical testing to a full service, GLP compliant CRO. Working with our client, we created a full Quality System which successfully supported cGLP practices and compliance.
The End Result
Thanks to the development of a Quality Management System that satisfied both the requirements of 21 CFR 58 and the requirements of one of its biggest customers, our client gained approval as an Approved Supplier. This solidified our client’s standing and ensured continued use in many of its customers’ additional locations.