PV Audits & Inspections: Quality system management in PV
Quality maintenance is not just a practice; it’s a cornerstone of Good Pharmacovigilance Practice (GPvP) and an obligatory responsibility for Marketing Authorization Holders (MAHs) and clinical trial sponsors.
At QbD Group, we recognize the critical need for a robust quality and safety framework, and our comprehensive services are designed to address every facet of this obligation.
Don’t hesitate to contact us for more information.
How can we help you?
Quality Management System (QMS)
Risk-based audit planning
Effective training and qualification programs
Robust systems for planning, performing, and reporting audits
Pharmacovigilance System Master File (PSMF)
Legal compliance for MAHs in the European Economic Area
Comprehensive documentation ensuring product safety
- Â
Additional Components
Standard Operating Procedures (SOPs) for streamlined processes
Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEA) for collaboration
PV Compliance: Metrics and KPIs monitoring
Audit support during Health Authority inspections
Preparation for Inspections
Preparing for government inspections by addressing weaknesses
Key Management RolesÂ
QPPV & QP training
- Â
Why QbD Group?
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
