Pharmacovigilance Inspections
Providing expert support at every stage of your PV inspection, for both human and veterinary medicinal products.
Stay ready for a PV inspection
As a Marketing Authorisation Holder, you may be contacted by authorities at any time to announce a pharmacovigilance inspection.
At Asphalion, we help companies prepare for, manage, and respond to PV inspections with confidence. We don’t just support individual inspections—we help ensure your PV system is inspection-ready by design.
How can we help?
We provide practical, end-to-end support across all stages of a PV inspection, including:
Pre-inspection
- PV inspection readiness assessments
- Routine audits
- EU-QPPV training
- Documentation and traceability review
- Inspection response preparation
During inspection
- Support during inspection execution
Post-inspection
- CAPA follow-up
Strategic Support for PV Inspection Excellence
Our goal is to keep your pharmacovigilance system structured, updated, compliant, and aligned with regulatory expectations at all times.
Why inspection readiness matters
A common early trigger is a request for the Pharmacovigilance System Master File (PSMF), which usually must be submitted within 7 calendar days. While this does not always mean an inspection will follow, it is often a strong indicator.
Being inspection-ready helps you to:
Reduce compliance risks
Strengthen EU-QPPV oversight
Improve traceability and documentation control
Respond clearly and efficiently to inspectors
Successful inspections depend on strong coordination, clear communication, and controlled documentation.
What inspectors expect
During a PV inspection, authorities typically assess whether your PV system is compliant, controlled, and supported by objective evidence.
They usually review:
- EU-QPPV oversight and system knowledge
- PSMF availability and consistency
- Complete, current, and approved documentation
- Clear, concise, and transparent responses during interviews.
Why Asphalion
At Asphalion, we act as your strategic PV partner, working alongside your team on a daily basis to ensure your pharmacovigilance system is robust, compliant, and always audit-ready.
Over the past two years, our PV team has participated in six PV inspections as the primary responsible party for the PV system, all successfully completed with zero critical findings.
Our experience includes:
- End-to-end inspection readiness and management
- Strong expertise supporting the EU-QPPV and PV system
- Proven ability to ensure compliance, consistency, and traceability
- Hands-on support during preparation, execution, and follow-up
A Free Practical Guide to Pharmacovigilance Inspection Readiness
A practical guide for Marketing Authorization Holders covering inspection notification, documentation readiness, team coordination, and key principles to help organizations stay structured, compliant, and in control.
Have a look at our success case!
An international company with global reach faced a PV inspection that resulted in 34 findings, including four critical ones.
Download the business case to see how Asphalion helped the company strengthen its PV processes and address the inspection findings.
Watch Our Technical Webinar!
Watch out webinar and take a proactive approach to PV inspections. Led by Asphalion expert and PV audits Marta González, this session goes beyond the basics, helping you anticipate risks, understand the most common findings, and strengthen your system before an inspection takes place.
Need support for your next pharmacovigilance inspection?
Talk to our PV experts and strengthen your inspection readiness today.
Schedule now a free meeting with our Pharmacovigilance experts!
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
ASPHALION’s experts have delivered solutions to over 1,500 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 10,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
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