SERVICES Quality Assurance

Need expert help identifying and remediating shortfalls within your Quality Management System (QMS)? Need to build or augment your Quality Assurance team with top talent? We help thousands of life science companies outsource their QA projects and fill specialized roles through convenient staff augmentation and recruitment.

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FUNCTIONAL AREA Quality Management Systems (QMS)

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidances, and best practices related to quality system management throughout the regulated life science industries.

  • GxP Audits

  • QMS Process & Procedure Development

  • Gap Assessments

  • QMS Remediation

  • Quality Unit Resourcing

Functional Area Non-Conformance & CAPA Management

Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.

  • Non-Conformance/Deviation Investigation Management Support
  • Process Analysis & Enhancement

  • Investigation, Action Plan, & Effectiveness Check 

Functional Area Regulatory Compliance

Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.

  • Regulatory Observation Responses & Remediation

  • PAI & Inspection Readiness

  • Internal Audit & Remediation Services

Engagement Models


Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Consulting Projects

Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

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ENGAGEMENT MODEL Staff Augmentation

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

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Engagement Model FTE Recruitment

We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

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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 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

  • 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

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of quality assurance requirements, 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 quality assurance 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.