DuVal & Associates PA

DuVal & Associates PA Introduce

The life sciences industry is a cornerstone of innovation in Minnesota, with a vibrant ecosystem of medical device, pharmaceutical, and biotech companies. For these companies, navigating the complex web of U.S. Food and Drug Administration (FDA) regulations is not just a legal requirement but a strategic necessity. A single misstep can halt a product launch or jeopardize a company's future. For businesses in the Twin Cities and beyond, having a dedicated legal partner with deep expertise in FDA law is paramount. This is precisely the specialized service that DuVal & Associates PA provides.

DuVal & Associates PA is a Minneapolis-based law firm with a unique and exclusive focus on FDA law and regulatory consulting. The firm, led by CEO Mark DuVal, is dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Their mission is to provide "real-world" and practical advice, helping clients navigate the regulatory landscape with confidence. Their team is comprised of seasoned professionals who have an intimate understanding of FDA processes, often leveraging excellent working relationships with FDA leadership.

The firm's reputation is built on its ability to offer a unique blend of legal expertise and practical industry knowledge. According to client testimonials, the DuVal team brings an "incredible amount of experience, practical thinking, and simple yet effective approaches to complex issues." For any company in Minnesota operating in the life sciences sector, this type of specialized and focused legal counsel is invaluable to ensuring both compliance and commercial success.

DuVal & Associates PA is located at 825 Nicollet Mall, Suite 1820, in the heart of downtown Minneapolis, MN 55402. This prime location is easily accessible for clients from across the Twin Cities metropolitan area. Situated in a central business district, the office is a convenient destination for meetings and consultations.

The firm is committed to ensuring a welcoming and accessible environment for all clients. The office building features a wheelchair-accessible entrance, which ensures that all individuals can enter the premises without difficulty. A wheelchair-accessible parking lot is also available, making the arrival and departure process simpler for those with mobility challenges. Furthermore, an on-site wheelchair-accessible restroom is provided, ensuring a comfortable experience for every visitor. This dedication to accessibility reflects the firm's client-centric approach to legal service.

To ensure that clients receive dedicated and focused attention, the firm recommends making an appointment in advance. This practice allows for a thorough and unhurried discussion of a client’s specific regulatory and legal needs.

DuVal & Associates PA offers a highly specialized range of legal and consulting services, all centered on FDA law and regulatory strategy. Their expertise is tailored to the unique needs of companies in the medical and life sciences industries.

FDA Regulatory Strategy and Consulting
Medical Device Regulatory Strategy
FDA Regulations and Compliance
Due Diligence Investigations
Premarket Submissions (e.g., 510(k)s, De Novos, PMAs)
Advertising and Promotional Review
Legal Services related to FDA inspections, warning letters, and appeals
Compliance Program Development
Team Support for client projects
Client Testimonials

This comprehensive list demonstrates the firm's deep knowledge and concentrated focus. By offering services that span the entire product lifecycle, from initial development to post-market compliance, the team provides a holistic and strategic approach to their clients' legal and regulatory challenges.

DuVal & Associates PA is distinguished by its unique features and professional standing within the niche field of FDA law.

Exclusive Specialization: The firm's exclusive focus on FDA law for the medical device, pharmaceutical, and biotech industries provides a level of expertise unmatched by general practice firms.
Industry Experience: Many members of the team have prior experience working in the industry, including CEO Mark DuVal's time as general counsel for 3M Pharmaceuticals and in corporate compliance at Medtronic.
Positive Client Testimonials: The firm’s website features glowing testimonials from clients who praise the team's ability to provide "real-world practical advice" and their respectful but direct approach with the FDA.
Respected Relationships: Clients highlight the firm's "deep and respectful relationships with FDA leadership," which they leverage to the benefit of their clients.
Appointments Recommended: The firm operates on an appointment-only basis, ensuring that each client receives dedicated and focused time.
Accessibility: The office is fully equipped with a wheelchair-accessible entrance, parking lot, and restroom, reflecting a commitment to accommodating all clients.

These features highlight a firm that is not only highly skilled but also deeply committed to providing a strategic and supportive experience for its clients. The client testimonials are a powerful testament to the firm's ability to deliver results and build lasting, trusting relationships.

To schedule a consultation or learn more about the legal and regulatory services offered, you can reach the firm using the contact information below.

Address: 825 Nicollet Mall Suite #1820, Minneapolis, MN 55402, USA

Phone: (612) 338-7170

Mobile Phone: +1 612-338-7170

As appointments are recommended, it is best to call ahead to secure a time to discuss your legal needs with their expert team.

For any company in Minnesota operating in the FDA-regulated space, choosing the right legal counsel is not a decision to be taken lightly. DuVal & Associates PA is worth choosing for several compelling reasons. The most significant is their unparalleled specialization. In an industry where regulations are constantly evolving and the stakes are incredibly high, a law firm that lives and breathes FDA law is a powerful asset. CEO Mark DuVal and his team’s extensive experience, including their prior roles at major companies like 3M and Medtronic, gives them an insider's perspective on the challenges their clients face.

The client testimonials provide concrete evidence of the firm's value. From helping a company navigate 510(k) submissions to providing critical support during urgent situations, the feedback consistently highlights the team's effectiveness, creativity, and availability. The praise for their ability to communicate with the FDA in a way that "clarifies questions and issues quickly and effectively" is a key indicator of their skill and the value they bring to the table. They are seen not just as legal advisors, but as an "instrumental partner" in their clients' success.

In a world where medical innovation is moving faster than ever, having a legal partner who can keep pace is essential. DuVal & Associates PA offers the deep expertise, strategic counsel, and trusted relationships needed to help Minnesota's medical device and pharmaceutical companies succeed. For any business looking for more than just a lawyer, but a true regulatory partner, this firm is an outstanding choice.