The Firm

FDA, and FDA-related work is all we do. 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.

Cradle-to-grave representation. It’s not cliche to say that we assist clients cradle-to-grave. We start at the inception of the product planning process where we advise clients "to begin with the end in mind" in developing product claims. We work with experts in marketing, product development, clinical, reimbursement and regulatory to combine their thinking to optimize the product submitted to FDA, and eventually marketed. We also help in quality systems, inspections, and addressing enforcement matters. We set up compliance programs, audit against them, and conduct management and sales training on FDA's advertising and promotion regulations, the Anti-kickback Statute, False Claims Act, the Physician Payments Sunshine Act, Foreign Corrupt Practice Act, and HIPAA. We assist with due diligence reviews and write opinions for companies. We help companies in every phase and aspect of their business life to meet their goals. We help you to be appropriately aggressive, yet compliant.

Unrelenting advocates. 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.

Our Team

We’ve done this before: both in-house, and as consultants. All of our attorneys have experience bringing medical technology to market, which is precisely what enables us to serve our clients so well. When you choose DuVal & Associates to represent you or provide you with insight, you're choosing over 100 years of combined experience in regulatory fields.

We cover a lot of substantive ground. Our attorneys have extensive backgrounds in the pharma and medical device industries in roles such as general counsel, as regulatory and compliance counsel, as an FDA investigator, and other in-house roles in development, clinical, regulatory and quality, and sales and marketing. We have supporting personnel who have conducted FDA audits and have made FDA submissions for decades. We understand the business of business, and the FDA. We help you to be appropriately aggressive, yet compliant.

Helping clients be appropriately aggressive, yet compliant. TM