Readiness Under Scrutiny
Regulatory inspections and partner audits are defining moments. Findings can range from minor observations to warning letters. The companies that perform best under scrutiny are those that maintain robust internal audit programs—identifying and correcting issues before inspectors arrive.
RegOps auditors bring extensive GxP experience across manufacturing, clinical, laboratory, and pharmacovigilance operations. We conduct audits with the rigor and perspective of regulatory inspectors, identifying compliance gaps and improvement opportunities. Our audit approach is thorough but practical, focused on findings that matter and recommendations you can implement.
Our Capabilities
Comprehensive audit coverage spanning the entire GxP spectrum.
Comprehensive audits of manufacturing, packaging, and quality system operations against current GMPs. We assess facilities, documentation, and personnel practices.
Audits of clinical trial operations including investigator sites and sponsor processes. We evaluate protocol compliance, data integrity, and subject safety.
Assessment of nonclinical study facilities and processes against GLP requirements. We audit study conduct, QA activity, archive management, and facility operations.
Evaluation of pharmacovigilance systems against GVP requirements. We assess case processing, reporting, signal management, and safety governance.
Qualification and ongoing audits of suppliers, CMOs, and vendors. We verify partner compliance and capability to support your quality requirements.
Simulated regulatory inspections that prepare your organization for actual agency visits. We replicate inspection dynamics and coach your team on responses.
The RegOps Advantage
We bring the inspector's perspective to help you build a audit-ready organization.
Inspector Perspective
We identify the issues that would catch agency attention and prioritize finding based on regulatory risk, mirroring an actual inspection.
Practical CAPA
Our audit reports include actionable CAPA recommendations that address root causes, not just symptoms.
Risk-Based Approach
We apply risk-based planning and execution, focusing effort on areas of greatest compliance and patient safety impact.
Program Development
Beyond individual audits, we help organizations build and mature internal audit programs that drive continuous improvement.