Auditing Services

An increasing number of public health concerns and challenges have underscored regulators’ proactive pursuit of compliance throughout all regulated industries.

Our quality professionals 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.

Our consultants 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.

Select a service below to learn more.

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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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