The Firm

History

DuVal & Associates was formed in 2004 with a mission to focus on serving companies regulated by FDA with their unique needs leveraging our exceptional industry experience, practicality, wisdom and responsiveness.

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 balance respect for the FDA and challenging them. DuVal & Associates believes a lawyer can advocate aggressively, yet diplomatically and with respect, and obtain better results for clients while maintaining the firm's and the client's positive relationship with FDA. DuVal & Associates has been doing that for years. We understand that a law firm must be focused on the needs of the client, not billable hours. We know that a firm should serve with distinction as a strategic partner, trusted advisor with real world insight gained from industry experience, and as successful advocates.

General

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.

For commercialization, 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.

Helping clients be appropriately aggressive, yet compliant.™