Reduce risk through thorough regulatory evaluation. Our experienced compliance professionals conduct comprehensive audits, helping ensure your clinical operations are prepared for demanding regulatory review.
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.
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.
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.
Contact our team to learn how our audit services can help strengthen your organization's inspection readiness.
Reduce risk through thorough regulatory evaluation. Our experienced compliance professionals conduct comprehensive audits, helping ensure your clinical operations are prepared for demanding regulatory review.
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.
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.
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.
Contact our team to learn how our audit services can help strengthen your organization's inspection readiness.