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GxP Auditing and Consulting Services

Expert Auditors & Consultants for GxP Standards

ENHANCING GxP COMPLIANCE SOLUTIONS AND SERVICES 

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About Us

At GxP Auditing and Consulting Services, we specialize in delivering 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.

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

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

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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.

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Bio

Leadership Profile

 

Ramzi W. Kozal, CQA


Founder & Principal Auditor


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. Ready to transform your GxP compliance? Contact Ramzi and see your savings with our Cost Savings Calculator in the previous page. â€‹

 

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.​

 

Call to Action

 

Partner with GxP Auditing and Consulting Services to strengthen your compliance framework and achieve operational excellence.

 

           Contact Us Today 

     

           Schedule a Consultation

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