Comprehensive Quality Assurance
Reduce risk through thorough regulatory evaluation. Our experienced compliance professionals conduct comprehensive audits, helping ensure your clinical operations are prepared for demanding regulatory review.
Compliance Audit Center
Mock Regulatory Inspections
Experience the intensity of a regulatory inspection before the real event. We simulate FDA BIMO and EMA GCP inspection methodologies, stress-testing your audit readiness and identifying vulnerabilities that others miss.
Vendor Qualification Ecosystem
Your oversight responsibilities extend to every partner. We deploy a risk-based qualification framework to rigorously assess CROs, central labs, and technology vendors, ensuring their quality systems harmonize with your compliance obligations.
Data Integrity Analysis
In the digital era, data integrity is paramount. Our experienced auditors perform thorough analysis of audit trails, metadata, and system logs to identify anomalies, unauthorized changes, or ALCOA+ compliance gaps before regulatory submission.
Discuss Your Compliance Needs
Contact our team to learn how our audit services can help strengthen your organization's inspection readiness.