Ex-FDA Consultants Connect with the industry's largest network of former FDA consultants.

    Navigating the complex regulatory landscape of the life sciences industry requires a partner not just experienced in, but fundamentally shaped by the very framework that governs it.

    At The FDA Group, we offer direct access to over 25o ex-FDA professionals, each bringing a wealth of regulatory insight and hands-on experience from the agency. Our network is your pathway to regulatory excellence, offering personalized consultation that addresses your unique challenges and propels your projects to success.

    We're also always looking for opportunities to grow our former FDA consulting network. If you're currently or formerly employed by the FDA and are looking for consulting opportunities, use the links on this page to join our network.

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    You deserve an FDA consulting partner that delivers the very best consultants.

    We are that partner.

    Our ex-FDA consultants deliver the deep regulatory expertise and guidance that only comes with those who've worked within the FDA itself. We exclusively serve the FDA-regulated industries, offering a depth of knowledge unmatched in the industry.

    As the consulting partner for thousands of firms, including 17 of the top 25 global pharmaceutical, biotech, and medical device companies, we connect you with the former FDA specialists you need at a competitive rate.

    • Exclusive life science focus and expertise
    • Dedicated account management team
    • Right resource, first time (95% success)
    • 97% client satisfaction
    • Total Quality Guarantee

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    Of the top 25 largest life science companies work with us

    Get former FDA assistance at every stage of the product lifecycle.

    We help life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our ex-FDA consultants assist in every stage of the product lifecycle.

    Expand the sections below to learn more about our consulting services and areas of expertise.

     

    Former FDA Q&A Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher Smith

    Christopher Smith is a former FDA investigator and current consultant for The FDA Group. He sat down with us to discuss PAIs and how to prepare for these inspections properly.  Chris has over 40 years of experience, having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations.

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    Find a consultant that fits your needed skillsets and background.

    Looking for a contracted professional with particular experience or skills? Use our consultant finder tool to browse a selection of our consultant CVs. Prefer to express your needs directly? Use our consultant search form to tell us what kind of resource you're looking for.

    Explore consultant CVs » Start a consultant search »

    Join our consulting team.

    At The FDA Group, we are always looking for top former FDA professionals to grow our network. If you can bring experience and new perspectives to our consulting team, we invite you to send us your resume.

    Learn more and submit resume »

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    Introductory Conversation

    • About Us
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    • Scope Of Work

    Resources Definition

    • Background And Expertise
    • Location Of Resource
    • Rate Rightsizing

    Proprietary Resource Selection Process

    • Recruiting Team External Search
    • In-House Subject Matter Experts
    • Resource Identification

    Resource Presentation

    • CV And Rate
    • Perfect Match Summary
    • Interview Call Coordination

    Agreement Processing

    • MSA And Addendums
    • Supplier Qualification
    • Kickoff Coordination

    Account Management

    • Project Management Of Resource
    • Satisfaction Management For Client
    • Total Quality Guarantee

    Our services are backed by a Total Quality Guarantee. If for any reason, you are dissatisfied with any service, we will provide you with a full refund.

    Since 2007, we've been documenting and excluding consultants who don't meet our high standards—protecting your projects from poor performance, lack of integrity, and slow response times. By suppressing these consultants from client engagements, we maintain a network of top-tier professionals that consistently deliver exceptional results.
     
    Talk to us when you're ready for a better talent resourcing experience and the peace of mind that comes with a partner whose commitment to quality and integrity reflects your own.

    Tell us about your consulting needs and get the conversation started.

    Tell us about your specific needs or simply indicate that you'd like a call-back to discuss your project. We'll follow up within one business day.