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GxP Compliance Consulting & Auditing Services

Expert Auditors & Consultants for GxP Standards

GxP auditing services
GxP auditing services

We Deliver Tailored GxP Compliance Solutions...

To the Biotechnology, Pharmaceutical, Radiopharmaceutical, Medical Device, and Dietary Supplement industries.

Our certified and experienced auditors and consultants provide end-to-end support across GxP standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).

We ensure our clients achieve regulatory excellence, maintain operational efficiency, and are always inspection-ready to meet the requirements of global health authorities such as the FDA, EMA, MHRA, and WHO.

Our GxP Compliance Services

GCP and GLP inspection prep

Biotech Services

Helping biotech firms meet strict GxP compliance standards.

GxP auditing services

Radiopharma Services

Supporting regulatory success in radiopharma operations.

GCP and GLP inspection prep

Dietary Supp Services

Ensuring GMP compliance for dietary supplement facilities.

GCP and GLP inspection prep

Pharma Services

Auditing pharma sites for FDA, EMA, and WHO readiness.

FDA audit support

Medical Devices Services

Guiding device companies through ISO and FDA audits.

FDA audit support

Pricing and Packages

Transparent pricing with tailored audit packages offered.

​Try our "Savings Calculator" and see how much you can save with us.

We cut your GMP/GCP/GLP audit cost by at least 15% compared to you current provider.

We offer no obligation review of your last audit invoice (redacted if needed) and provide you with one-page breakdown of how we do it cheaper, better and faster.​​

Audit Cost Savings Calculator

Enter your current audit expenses to see your savings with GxP Auditing.

Please fill in all fields before calculating.

GMP compliance consulting

Your Estimated Savings

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Savings Breakdown:

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We optimize every cost to save you at least 15%!

Meet Ramzi W. Kozal, CQA

Founder & Principal Auditor

GMP compliance consulting

Ramzi is a Certified Quality Auditor (CQA) with over 25 years of leadership in quality assurance, quality control and regulatory compliance across biotech, pharmaceuticals, radiopharmaceuticals, and dietary supplements.

Renowned for hosting numerous FDA inspections with many resulting in zero major findings, he’s saved clients up to 30% on audit costs by streamlining processes and leveraging global expertise in 21 CFR Parts 11, 58, 111, 211, and 212.

From implementing cutting-edge Quality Management Systems (QMS) that slashed deviations by 15% to managing multi-site QA teams across continents, Ramzi delivers compliance and efficiency with unmatched precision.

Fluent in several languages, and versed in ICH, EMA, and USP standards, he’s your trusted partner to navigate complex regulations affordably.

Our Commitment to Quality

Our auditors are dedicated to building high-performing teams, delivering effective training programs, and fostering a culture of proactive risk management. By implementing CAPA systems and supplier qualification programs, we help organizations enhance efficiency and maintain regulatory readiness.​

GMP compliance consulting

Strengthen your compliance framework and achieve operational excellence.

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