Our customer had a series of pharmaceutical and biological products that had been on the market in various countries for 10 years or more. Over time, they had made a number of manufacturing improvements, and they needed to update their myriad licenses.
The task was enormous – auditing some 220 Marketing Authorization (MA) dossiers and ultimately preparing about 430 variation submissions. It was a substantial, and urgent, assignment for the customer’s in-house regulatory staff, and it came on top of their significant ongoing new product responsibilities.
The company trusted Quintiles to handle the entire project, and – equally important – to ensure timely delivery.