Quality Assurance Auditing Services

We perform detailed assessments of your existing quality system, identify current and potential problems, recommend corrective and preventive actions, and work closely with your staff to implement these improvements to your quality system. We analyze FDA’s inspection history using predictive language to determine your risk for future inspections and can assist you with all aspects of compliance, including but not limited to, GMP, GCP, and GLP.

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Concerned your quality system doesn't reflect FDA expectations?

We'll pair you with former FDA and industry professionals who have extensive knowledge of FDA's current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.

  • No significant FDA-483 observations following inspections
  • No FDA warning letters
  • No delays in approval of PMA’s or NDA’s because of quality system deficiencies
  • No mention of your company name in FDA Enforcement Reports


Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.

Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf. 

Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.

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GMP Auditing

We bring direct experience in pharmaceutical, biologic, and medical device and diagnostic manufacturing to help you with GMP quality assurance.

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GCP Auditing

Our team conducts study-specific GCP audits of protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports for a wide variety of clinical studies all over the world.

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GLP Auditing

Our quality assurance personnel provide comprehensive auditing services for all types of laboratories.

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Vendor/Supplier Auditing

Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations.

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Pharmacovigilance Auditing

Assess and maintain compliance with your pharmacovigilance program.

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Data Integrity Auditing

Our data integrity, validation, and quality experts perform comprehensive computer systems and data assessments to ensure your system requirements are fully met and adequately documented.

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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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Continuous Auditor Education

The FDA Group is dedicated to ensuring our auditors are always ahead in the ever-evolving regulatory landscape. Our Insider Newsletter provides bi-weekly updates on the latest FDA and related regulatory news, from new guidelines to enforcement actions.

Additionally, our newsletter offers monthly in-depth analyses of recent regulations, available in both written and video formats, crafted by our expert consultants. Our commitment to continuous education ensures our clients receive top-notch, compliant, and future-ready service.

Join us in staying informed and subscribe to the Insider Newsletter, available to everyone in the FDA-regulated industries.

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Auditor Requirements

  • Backgrounds And Expertise
  • Location Of Resources
  • Rate Rightsizing

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Pre-Scope Coordination

Proprietary Resource Selection

  • In-House Search For Auditors
  • Auditor Identification
  • Auditor Vetting

Auditor Presentation

  • Curriculum Vitae
  • Perfect Match Summary
  • Interview Call Coordination

Pre-Scope Auditor Meeting

  • Detail Gathering
  • Expectations Definition
  • Timelines And Deliverables

Dedicated Project Management

  • Audit Conduct
  • Checkpoint Communications
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of auditing 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 our auditing services. 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.