Service Areas We are a global leader in life science consulting, staff augmentation, FTE recruitment, remediation, and auditing.

Get rapid access to the life science resources you need to fill specialized roles and execute projects on-time and on-budget. We offer a unique combination of experienced technical recruiting and project management capabilities to deliver both staffing/recruitment and project-based consulting solutions through your preferred engagement model.

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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.

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Services Regulatory Affairs

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

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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.

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Services Commissioning, Qualification & Validation

Need third-party project or resourcing assistance to support commissioning, qualification, and/or validation activities? We can provide the expertise and capability you need no matter which role you need to fill or which phase your project is in.

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Services Chemistry, Manufacturing, and Controls (CMC)

Need expert help navigating regulatory, scientific, and technical challenges to ensure compliance, bolster your production capability, and guarantee timely delivery? We help you achieve your next milestone by offering our expertise in all aspects of CMC development, including product, process and test method development, product stability testing, phase-appropriate validation, packaging development, and manufacturing and testing under GMP conditions.

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Services Pharmacovigilance

Our consultants, many of whom are former FDA, are experts in the science and activities related to detecting, evaluating, understanding, and preventing adverse effects associated with pharmaceutical and medical device products. Teams work with us when they want to ensure the safety of their products throughout their lifecycle.

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Services Expert Witness

Interpreting and acting on FDA regulations can be difficult and complex. We connect you to former FDA officials and public health officials who regularly serve as knowledgeable expert witnesses.

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Why work with The FDA Group?

  • 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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Our resources can be utilized to meet the wide range of requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


Please contact us to learn more about fulfilling specific life science project support or resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.