Compliance QC™ Case Study

Centerfirst speeds expert compliance monitoring service to top-5 global pharma company in coordinated response to regulatory agency inspection

Background – A routine inspection found potentially tens of thousands of unreported adverse events from contact center interactions. Our client was facing fines of literally hundreds of millions of dollars. Immediate correction action was required.

Actions – Centerfirst expertly implemented its Compliance QC™ service which immediately brought decades of regulatory experience to bear on the problem. The corrective action program required expertise in all facets of monitoring—accelerated staffing and training, impeccable execution, secure online access to data and reporting, and remote access into corporate systems—all completely within a FDA inspection-ready environment.

Results – Centerfirst executed on the program which led to Centerfirst being named in our clients CAPA response to the regulator.

Client Pharmacovigilance Director – “We knew Centerfirst had the expertise, but what made the difference is how they were able to quickly put the solution into action.”