People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to … Read more
With the evolution of pharmaceutical industry over the past decades, compliance remains a key factor in bringing novel drugs to market. Proregulations, as a product safety and regulatory consulting firm with a long-standing core mission of “Value in Compliance”, announces to offer a series of DMF document production and filing services, helping clients worldwide navigate the FDA approval process in a faster and … Read more