Empirical Europe 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.



    When it comes to FDA submission and approval, we understand that time is of the essence because wasted time translates to wasted money. That’s why we’re proud to obtain FDA clearance 20-30% faster than the industry average on a regular basis. This means that rather than waiting extra weeks or months to hear back from the FDA following submission, you will likely be able to get your product to market considerably faster when you utilize consulting services from Empirical.

  • HIGH LEVEL Of expertise

    Our team offers more than 40 years of combined regulatory and consulting experience, and every member of our staff is RAPS trained and/or certified (RAC). This level of expertise is evidenced by our 100% success rate in FDA submission clearance. We take the knowledge of our staff seriously, so you can rest assured that even the most finite details will not be overlooked.

  • long-standing relationship

    Investing in FDA compliance consulting with Empirical means capitalizing on our long-standing relationship with this regulatory agency; we understand what it takes to achieve clearance, and we work hard to ensure that our clients’ submissions are as thoroughly prepared as possible. The process of submitting a product for FDA approval is extremely involved and requires careful attention to detail, as well as industry-specific insight; Empirical will help you navigate this complicated system with dexterous skill so you can reap the benefits of your hard work.


To learn more and engage with an FDA compliance consultant at Empirical Technologies.