Customer Success Story
Regulatory Compliance Case Study
Centerfirst delivers expert compliance monitoring service to a top-5 global pharma company in a coordinated response to regulatory agency inspection.
A routine inspection found potentially tens of thousands of unreported adverse events from contact center interactions. Our client was facing fines of hundreds of millions of dollars, and immediate corrective action was required.
We knew Centerfirst had the expertise, but what made the difference is how they were able to quickly put the solution into action.-Client Pharmacovigilance Director
Centerfirst expertly implemented its regulatory compliance service which immediately brought decades of regulatory experience to help solve 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 an FDA inspection-ready environment.
Centerfirst executed on the program which led to Centerfirst being named in our client's CAPA response to the regulator.