Meeting regulatory requirements for your new drug, biologic, medical device or combination product is an obvious essential, and Quintiles can help you choose the optimal regulatory pathways for the U.S., Europe and globally.
Our services cover a product's full lifecycle, including preclinical development, product development strategy, documentation, submissions, quality systems, supplier qualification and postmarketing surveillance. We also offer CE Marking and Authorized Representative services specifically for the EU market.
But it takes more than just satisfying regulatory requirements to ensure the success of your product. Read how Quintiles can help.