GxP Auditing
GxP Cellators – Global Experts in GxP Auditing and Compliance
GxP Cellators is a specialized consulting firm dedicated to delivering expert auditing and compliance services across the global pharmaceutical, biotechnology, and life sciences industries.
Our mission is to ensure that your operations comply fully with international Good Practice (GxP) standards, protecting patient safety, product integrity, and regulatory reliability.
We bring a deep understanding of GMP, GLP, and GCP principles along with years of expertise auditing complex organizations and regulated environments.
Our Core Services
Comprehensive GxP Auditing
At GxP Cellators, we conduct end-to-end audits designed to assess, evaluate, and strengthen compliance frameworks across multiple segments of the life sciences industry. Our audits cover:
Good Manufacturing Practice (GMP)
Good Laboratory Practice (GLP)
Good Clinical Practice (GCP)
Audit Coverage Areas
We provide independent, third-party assessments across a variety of regulated entities, including:
- Pharmaceutical manufacturing facilities
- Contract Manufacturing Organizations (CMOs)
- Contract Research Organizations (CROs)
- Animal testing facilities and laboratoriesP
- Investigator sites and clinical trial centers
Each audit is meticulously tailored to the applicable regulatory framework, operational scope, and quality system maturity.
Regulatory Frameworks and Standards
Our auditing and compliance services align with major international regulatory guidelines and industry standards, including:
- EU-GMP (European Union Good Manufacturing Practice)
- US FDA cGMP (Current Good Manufacturing Practice)
- GCP & GLP compliance standards
- Health Canada GMP & GCP
- TGA (Therapeutic Goods Administration) – Australia
- MCC (Medicines Control Council) – South Africa
- WHO GMP and GLP requirements
- OECD GLP principles
- 21 CFR Part 58 – Non-Clinical Laboratory Studies
Through these standards, we help clients maintain full compliance and readiness for regulatory inspection or partner qualification.
Why Choose GxP Cellators
- Global Reach & Local Expertise: Auditors with hands-on experience across major regulatory regions.
- Tailored, Risk-Based Approach: Every audit is customized to your organization’s operational complexity and risk profile.
- Regulatory Insight: Deep knowledge of evolving global health authority expectations.
- Actionable Reporting: We provide detailed, practical recommendations to close gaps efficiently.
- Trusted by Industry Leaders: Our clients include top-tier pharmaceutical, biotech, and research organizations worldwide.
Partner with GxP Cellators
Whether you’re preparing for a regulatory inspection, qualifying a supplier, or strengthening your internal quality systems, GxP Cellators delivers trusted expertise to ensure your operations are always audit-ready.
Email:
Website: www.gxpcellators.com
