Empirical Technologies has worked as an FDA regulatory compliance partner for more than 20 years; with practical expertise and technical insight to offer, we can make the process of preparing your product for FDA submission far simpler. Our professional staff brings industry-specific knowledge and regulatory insight to every partnership.
As FDA compliance consultants, Empirical takes an active role in assisting clients with the approval process. Our FDA compliance services include regulatory support, quality system development and improvement, 510(k) submission, and much more, so you can enjoy a streamlined and expedited path toward getting and keeping clearance.
The Food and Drug Administration (FDA) is responsible for ensuring that all food, cosmetics, pharmaceuticals, and medical devices in the United States are safe and/or effective for consumer use.
This being the case, the FDA regulatory compliance process is necessarily quite stringent; it involves clearing products for sale and distribution in the U.S., reviewing products, and maintaining surveillance of after-market products.
At Empirical, we assist clients in obtaining clearance, and we have proudly enjoyed a great deal of success in this arena. We have achieved more than 200 successful 510(k) submissions with an average review time of just 131 days—that’s 46 days faster than the industry average of 177 days. This is just one of the ways that Empirical is working to redefine the industry standard for FDA compliance consulting; our sector-specific expertise allows you to navigate the regulatory process more seamlessly with a customized approach, so you can achieve FDA compliance faster and more efficiently.