PV & QA Support, Made Simple
We help organizations build, strengthen, and optimize pharmacovigilance quality systems so they remain compliant and inspection-ready.
PV Quality System Development & Optimization
- Development and implementation of PV Quality Management Systems (PV QMS)
- SOP creation, review, and gap analysis
- Quality documentation structuring
- Risk-based compliance assessments
- QMS health checks and system optimization
Audits & Inspection Readiness
- Internal PV audits
- Vendor and partner audits
- Audit program design and management
- Mock inspections
- Inspection readiness assessments
- CAPA development and remediation support
- Post-inspection compliance strategy
Vendor Oversight & Compliance Management
- Oversight of outsourced PV activities
- Vendor qualification and performance monitoring
- Quality metrics development
- Deviation and change control management
- Signal management compliance review
- PV agreement quality review
Training & Advisory
- Customized PV QA training
- Inspection readiness workshops
- QMS and compliance awareness training
- Management advisory support
- Ongoing quality oversight consultancy