Get the right resource the first time—wherever and whenever you need them

Bringing in outside RA/QA help shouldn’t feel risky. At The FDA Group, we remove the uncertainty. Our proprietary matching process connects you with proven subject matter experts who fit your exact needs—whether for high-level strategy, hands-on execution, or both.

Our consultants integrate quickly, work independently within your systems, and are backed by our internal support team and full performance guarantee. They’re not just qualified—they’re accountable, adaptable, and built to deliver measurable results.

From initial planning through final execution, we help you move critical projects forward with speed, precision, and confidence—guaranteed.

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Register Get your products to market faster

Navigate complex regulatory pathways with former FDA reviewers who've evaluated hundreds of submissions. We know what gets approved and why—turning your innovations into marketed products.

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Analyze Find compliance gaps before the FDA does

Uncover vulnerabilities with comprehensive assessments led by former FDA investigators. We know exactly where regulators look and what triggers observations—helping you achieve inspection readiness.

Audit & mock inspection services »

Support Scale your team with the right contracted expertise

Access specialized talent exactly when you need it. From individual experts to entire departments, we provide the resources that integrate seamlessly and deliver immediate value.

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Remediate Turn compliance problems into sustainable excellence

When problems arise, rapid response matters. Our remediation teams—including former FDA officials who've issued the very observations you're addressing—know how to stabilize situations while building long-term solutions.

Remediation services »

You deserve a resourcing partner that lives and breathes life science.

We are that partner. We help thousands of firms within the FDA-regulated industries find the resources they need, when and where they need them, through the optimal workforce model.

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Exclusive life science focus and expertise

Dedicated account management team

Right resource, first time (95% success)

97% client satisfaction rating

Total Quality Guarantee

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Of the top 25 largest life science companies work with us

Access a worldwide network of life science professionals

Our large, global consulting network gives you convenient access to local experts across the entire contiguous U.S. and much of the world.



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Awards & Accreditations

Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

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

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At The FDA Group, we're committed to providing exceptional services backed by our Total Quality Guarantee. If, for any reason, you are dissatisfied with our services, we will provide 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.

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FEATURED RESOURCE Preparing for the QMSR: A Guide and Gap Analysis Worksheet

The medical device industry is on the cusp of a significant regulatory shift as the FDA harmonizes the QSR with ISO 13486:2016. Is your organization ready? Our new white paper and gap analysis worksheet are your essential guides for transitioning from the FDA's QSR to the new Quality Management System Regulation (QMSR).

Sign up for a paid subscription to our Insider Newsletter for access to both of these resources.

QMSR gap analysis worksheet »

Get in touch Join the thousands of life science companies executing their projects with The FDA Group.

The FDA Group sets itself apart from traditional consulting firms through its client success and satisfaction rate, and its dedication to the life sciences.

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