The FDA Group helps life science organizations rapidly access the industry's best RA/QA consultants and contractors. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization.
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.
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.
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.
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.
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.
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.
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.
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).
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