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GxP Compliance Consulting & Auditing Services

​Expert GxP consultants and auditors helping you stay compliant and inspection-ready.

GxP auditing services
GxP auditing services

Tailored GxP Compliance Consulting Services for Regulated Industries

We provide specialized GxP compliance consulting and auditing services to organizations in the biotechnology, pharmaceutical, radiopharmaceutical, medical device, and dietary supplement sectors.
 

Our certified auditors and consultants deliver comprehensive support across GxP standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
 

At GxPAuditConsult, we help clients build strong quality systems, improve operational efficiency, and maintain readiness for inspections by global regulatory agencies such as the FDA, EMA, MHRA, and WHO.
 

Whether you're preparing for a GMP audit or strengthening your internal compliance frameworks, our team is here to guide you at every step

Our GxP Compliance Consulting & Auditing 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 & Compliance

Expert-led training to strengthen internal quality and compliance teams

CAPA system implementation that addresses root causes and drives improvement

Supplier qualification programs aligned with GxP and regulatory expectations

Ongoing risk management to support a proactive quality culture

Audit readiness support that ensures your operations meet FDA, EMA, and WHO standards

Strengthen your GxP compliance systems with expert consulting and auditing support.

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