The FDA Group offers GxP auditing, remediation, quality system resourcing, and expert witness services to the pharmaceutical, biotechnology, medical device, and diagnostics industries. Explore our services pages to learn how we can help you evaluate, correct, and maintain your quality system.

Auditing

We pair you with former FDA and industry professionals with extensive knowledge of the FDA's current inspection expectations to ensure you're meeting all FDA regulations.

GMP Auditing →
GCP Auditing →
GLP Auditing →
Pharmacovigilance Auditing →
Vendor/Supplier Auditing →

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Quality System Remediation

Our experienced quality professionals take a hands-on approach to solving quality and compliance issues by developing and implementing comprehensive quality system remediation projects. This may be in response to your own internal audits or a recent inspection by FDA or your Notified Body.

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Quality System Resourcing

Our large staff of quality professionals work closely with your team to evaluate your current quality system, correct deficiencies, and support continuous improvement to maintain a compliant system.

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Regulatory Affairs

Our regulatory affairs specialists have years of experience working with the FDA throughout the pharmaceutical, biotechnology, medical device and diagnostic industries.

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Expert Witness

Our expansive staff of expert consultants ensure you will be paired with the right expert for your specific case.

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Training

Our large group of former FDA officials and industry experts lend decades of experience and an intimate knowledge of the regulatory environment through customized FDA training programs. We design our training sessions to help your organization master the complexities of drug, device, and biologic compliance.

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