QUMAS Compliance Solutions for Generic Drug & API Manufacturers

The key to the success of any Generic Drug or API manufacturer is the ability to control costs while consistently producing a reliable product of high quality. The Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in July 2012, and the Generic Drug User Fee Act (GDUFA) came into force on the 1st of October, 2012. Generic Drug and API Manufacturers are now living in a very different world. Faced with the ever growing burden of Regulatory Management around the globe, today’s generics companies need to be able to market their products in as many regions as possible, and do so quickly in order to realize a return on their investment.