Connecting you to the industry’s top talent... Guaranteed.

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

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

Finding top talent in the hyper-competitive life science industries gets harder each day. With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee.

Get direct access to the specialized life science talent you need to bring products to market and keep them there. Whether you’re looking for consulting or project support, full-time contract, contract-to-hire, or direct-hire talent, we rapidly identify the right resource, the first time.

Service areas » Engagement models »

SERVICES Quality Assurance

Build or augment your Quality Assurance team with top talent or outsource projects to an expert third party. We help thousands of life science companies find specialized resources and drive their projects to completion on-time and on-budget.

Quality Assurance services »

Services Regulatory Affairs

Develop and submit applications alongside former FDA and industry experts or fill in-house roles with select talent.

Regulatory Affairs services »

Services Clinical Operations

Maximize cost-effectiveness, flexibility, and scalability when building a partial or full in-house clinical operations team through rapid, reliable access to experienced clinical experts.

Clinical Operations 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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Consultants in our global network

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Former FDA personnel

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Average time to present a consultant

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Countries we have resources located in

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Of the top 25 largest life science companies work with us

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

Contributors to

  • cnn
  • bloomberg
  • msnbc
  • The New York Times logo
  • AP
  • fox business
  • NPR logo

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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Free guide Inside FDA's Proposed Rule to Regulate LDTs

The FDA proposed a new rule in Fall 2023 that would end the policy of enforcement discretion for LDTs. Once the final rule is issued, labs may have as little as one year to meet Stage 1 requirements, including filing medical device reports (MDRs) and notices of correction and removal.

We've identified the key questions for labs to consider, covering reporting, staff awareness, documentation, quality, and decision-making. Download our free guide to prepare for the possible end of discretion enforcement of LDTs.

Get the guide »

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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