Quality & Audit Services
Comprehensive GxP audit and quality assurance solutions. We ensure your clinical programs maintain the highest standards of data integrity and global regulatory compliance.
Standard
Full GxP Oversight
Readiness
Inspection-Ready Data
Compliance
Assurance
Integrity Auditing
Independent, objective assessments specifically designed to identify gaps and ensure total trial transparency.
Rigorous Oversight for
GxP Integrity
Abiozen provides a robust suite of GxP audit and quality assurance services specifically designed for the pharmaceutical, biotechnology, and medical device sectors. Our mission is to mitigate risk and ensure data integrity across the entire clinical development lifecycle.
"We provide independent, objective assessments that identify potential gaps and ensure your trial is inspection-ready at all times."
Total Compliance
Adherence to GCP, GLP, and GMP standards across all auditing activities.
Quality Assurance
Systematic monitoring to ensure processes fulfill stringent quality requirements.
Our Audit Portfolio
Specialized auditing across facilities, data systems, and clinical operations.
Clinical Operations
- GCP / Investigator Site Audits
- Phase I Facility Audits
- BA / BE Audits
- TMF (Trial Master File) Audits
Data & Systems
- Data Management & EDC Audits
- Safety Database Audits
- CSR (Clinical Report) Audits
- Archival Audits
Quality & Vendors
- QMS Auditing
- Central Laboratory Audits
- Third-Party Vendor Audits
- Inspection Readiness Reviews