GVP & GCP Audit Excellence
Inspection-ready audits aligned with global regulatory expectations and real-world regulatory pressure.
What this includes:
GVP and GCP vendor qualification, routine, and for-cause audits
GVP and GCP sponsor audits
FDA mock inspections (on-site and remote)
Sponsor oversight model evaluation
TMF and safety data flow assessment
What makes US different:
Audits are conducted with deliberate unpredictability and a focus on how regulators actually evaluate systems—not how organizations expect to be assessed.
Outcomes:
Clear identification of regulator-prioritized risks
Strengthened sponsor oversight and accountability
Audit outputs aligned with inspection readiness
READY TO STRENGTHEN YOUR COMPLIANCE?
Connect with Sussex Business Solutions to explore practical solutions for regulatory risk and quality system performance.