1. Site Audits – Independent assessment of GCP compliance, subject protection, documentation, data integrity and site processes.

2. CRO Qualification & Audits – Risk-based qualification and assessment of CRO capabilities, quality systems, compliance and operational controls.

3. Vendor Qualification – Evaluation of critical vendors and service providers to identify quality, compliance and operational risks.

4. Inspection Readiness – Practical assessment and preparation to help teams understand their current state and strengthen readiness for regulatory inspections.

5. Gap Identification & Risk Assessment – Identification of compliance gaps, critical risks and opportunities for improvement, with a focus on practical and sustainable remediation.