DuVal & Associates is a boutique law firm located in Minneapolis, Minnesota that specializes in FDA regulations for products at all stages of the product life cycle. Our clientele includes companies that market and manufacture pharmaceuticals, medical devices, biologics, nutritional supplements, and foods. These clients range in size from global Fortune 500 companies to small start-ups.
Helping clients be appropriately aggressive, yet compliant. We bring pragmatism and unapologetic advocacy. Our President and CEO, Mark DuVal, spent 17 years in-house between 3M Pharmaceuticals and 3M Medical Devices and Medtronic. As a general counsel, he used to hire regulatory and compliance counsel from the big law firms in Washington, D.C. and felt they were often impractical, too expensive and not very responsive to the exigencies of business, and did not deliver the results he needed. He often felt short-changed by these firms. They were afraid to advocate hard for clients because they are always fearful of not remaining friendly with the Agency. DuVal & Associates was formed in 2004 to fulfill the need for a team of experienced regulatory lawyers
We are unrelenting advocates for our industry, constantly taking positions on FDA initiatives. We comment on new FDA regulations and guidance. We take members of Congress on tours of medical device and pharmaceutical firms, continually helping Congress better understand the burden of regulation on industry and its impact on innovation and investment in innovation. We file Citizen Petitions challenging FDA’s administration of it's programs, write opinion editorials and speak with and debate FDA from the podium. We congratulate and applaud FDA for good work and challenge them when improvement is needed. We are opinion leaders in our field.
In working with FDA, we cover a lot of ground. Our clients' needs range from obtaining IND and IDE approvals, negotiating Pre-Submission meetings, obtaining product approvals or clearances (NDAs, ANDAs, 510(k)s, PMAs, HDEs, Orphan Designations) and CE Marks, filing Requests for Designations (RFDs) for combination products, reviewing compliance with quality systems and UDI, addressing inspectional problems, responding to warning letters and interacting with FDA at all levels from field investigational staff and biomedical product reviewers, to Branch Chiefs and the Commissioner.
We cut through the confusion to give practical, clear advice. We also help companies navigate the highly-regulated promotional landscape by reviewing promotional literature, websites, social media strategy, direct-to-consumer advertising and the like. We establish promotional compliance programs, audit them and train management teams and sales forces on the law (advertising and promotion, Anti-kickback Statute, False Claims Act, HIPAA, and Physician Payments Sunshine Act), industry codes of conduct, and company policy. We help clients to be appropriately aggressive yet compliant in their promotional efforts. We also work on enforcement matters of all types from warning letters and seizures to consent decrees and deferred prosecution agreements.