Our pharmacovigilance audit consultancy services
Our GVP services are designed for organizations seeking independent assurance, regulatory confidence and alignment of pharmacovigilance within their broader GxP landscape.
Independent GVP audits, auditors and quality specialists
Objective, inspection-focused audits including PASS, Process, System, Vendor, Affiliate, RSI and RMP audits, aligned to global GVP modules and regional regulatory requirements.
Pre/post inspection readiness support
Practical preparation for regulatory inspections, including readiness assessments, gap analysis and interview coaching.
Risk-based remediation and CAPAs
Clear prioritization and justification of findings enabling proportionate CAPAs grounded in regulatory expectations.
PV governance and quality systems
Support the design and enhancement of PV governance and QMS systems, including SOP and PSMF development, strengthening oversight and integration of PV activities within the QMS.
Global and local regulatory alignment
Worldwide support tailored to local regulatory requirements while maintaining consistent global oversight.
End-to-end GxP integration
Pharmacovigilance aligned within your wider GxP and quality framework, ensuring consistent oversight, unified governance and one solution across all regulated activities.
