• Mark DuVal quoted in FDAWebview article: "Always Slow, in this Case FDA Moves at Lightning Speed"

    • Published on: April 27, 2017
    • Category: Firm News

    DuVal & Associates President and CEO Mark DuVal was quoted in a follow-up FDAWebview article by Jim Dickinson, offering further comment on a situation outlined in an earlier article:

    In part, the story is flattering because so much clout is attributed to our firm. In part, it ascribes more clout than we have. Two points: first, we are respected by FDA and, we greatly respect them. Second, if that helps our clients get their side of the story and the truth told then we’ve done our job. Our job is to take the facts and the law and regulations and persuasively present them to the FDA. We do great work and we are proud of it. Again, the results speak for themselves because FDA agreed with our position.

  • Mark DuVal quoted in FDAWebview article: "When FDA Goes To Bat For One Company Against Another"

    • Published on: April 17, 2017
    • Category: Firm News

    DuVal & Associates President and CEO Mark DuVal was quoted in an FDAWebview article by Jim Dickinson which highlights the strength and quality of the firm's relationship with FDA:

    The FDA is a very data driven, fair-minded, consumer-safety driven agency. Anything we brought to their attention was independently verified by dedicated and astute agency personnel. I don’t think anyone for a minute believes the FDA would conspire with our firm or any other firm. We have good and respectful relationships there, but often our job is to challenge their thinking and advocate for our client. It helps when the law and regulations are on our side....

  • St. Cloud State Regulatory Affairs and Services (RAS) Program Interview with Mark DuVal

    • Published on: January 12, 2017
    • Category: Firm News

    Mark DuVal was interviewed for the St. Cloud State Regulatory Affairs and Services program.

    We're going to produce graduates who understand the medical device arena, and understand it well.

  • Welcome to the Firm, Mimi Passalacqua!

    • Published on: August 13, 2018
    • Category: Firm News

    DuVal & Associates, P.A. is growing! This year has proven to be a period of growth for us. We are under construction and expanded our offices. We are pleased and excited to announce the addition of a Regulatory Consultant - Mimi Passalacqua - to our team.

    Mimi brings a decade’s worth of experience working in the life sciences industry providing strategic and operational leadership in the areas of global regulatory affairs and promotional compliance. Prior to working with DuVal & Associates, she has worked with companies such as Zimmer Biomet, Smiths Medical, and Upsher-Smith Laboratories.

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Helping clients be appropriately aggressive, yet compliant. TM