For PV Leaders Accountable for Inspection Outcomes
INDEPENDENT PV AUDITS. INSPECTION READINESS. STRATEGIC QUALITY SUPPORT.
Always‑Ready Pharmacovigilance.
Practical. Defensible. Every Day.
1. INDEPENDENT PV AUDITS
Independent assurance. Meaningful challenge.
Need an experienced independent PV auditor?
SMPV Limited provides risk based audits of PV systems, processes and third parties, helping you identify gaps and understand what they may reveal about the wider system.
An audit should do more than produce findings.
It should give leadership better visibility of risk, control and what deserves attention next.
Best suited when:
• An audit is required within your audit programme
• You need independent assurance over a PV activity or system
• A vendor or third party needs auditing
• You need experienced PV quality challenge
2. InSpection readiness
Be ready to explain, evidence and defend your PV system.
Whether an inspection has been announced, is expected, or readiness feels uncertain, SMPV helps you understand how your system will stand up under regulatory scrutiny.
Our PV Always-Ready Framework:
Clarify → Strengthen → Stress Test
Clarify where exposure sits.
Strengthen priority areas.
Stress Test the system under realistic inspection scrutiny.
The goal is not simply to prepare for one inspection. It is to build greater confidence in how the system operates and responds under challenge.
3. STRATEGIC PV QUALITY & OVERSIGHT
Know where to focus before circumstances decide for you.
No inspection approaching?
That does not necessarily mean there is nothing to assess.
When resources are limited, leadership needs clarity on:
• Where risk is changing
• Where oversight deserves greater attention
• Whether existing controls provide the right visibility
• What should be prioritised now
• Where intervention could make the greatest difference
SMPV Limited provides an independent perspective to help PV leaders identify what matters and prioritise attention before an audit, inspection or significant issue dictates the agenda.
COMPLIANCE THAT FITS. CONFIDENCE THAT LASTS.
Clarity
Confidence
Clarity
See what is actually happening.
Understand how the system operates in practice, where risk sits and where evidence or accountability may be unclear.
Control
Confidence
Clarity
Know where attention is needed.
Strengthen governance, oversight, decision making and controls around priority areas.
Confidence
Confidence
Confidence
Know the system can withstand challenge.
Build confidence that leadership and teams can explain, evidence and defend how the PV system operates.
Make the real system visible.
Prove the system under real scrutiny.
Make the real system visible.
Understand how your pharmacovigilance system actually works and where accountability or evidence is unclear.
Build predictable control.
Prove the system under real scrutiny.
Make the real system visible.
Stabilise governance, oversight, and evidence generation. Targeted improvements focused on ownership, decision‑making, vendor oversight, and sustainability.
Prove the system under real scrutiny.
Prove the system under real scrutiny.
Prove the system under real scrutiny.
Challenge the system under real inspection scenarios. The objective is not rehearsal, but confidence that the system holds up because it is understood and controlled.
WHY SMPV Limited?
Senior expertise. Independent challenge. System level thinking.
SMPV Limited is not designed to be everything to everyone.
We work with pharmaceutical and biotechnology organisations that are serious about understanding and strengthening their PV systems.
What makes our approach different?
✓ Senior PV quality expertise throughout the engagement
✓ Independent, risk based challenge
✓ Deep understanding of PV systems and regulatory expectations
✓ Ability to connect individual issues to wider governance, oversight and system weaknesses
✓ Practical recommendations focused on what matters
✓ Experience across UK, EU and US inspection environments
What we are not/do not provide:
• Outsourced PV or quality operations
• Generic procedure or template providers
• Additional operational resource
• A large programme delivery consultancy.
Our Expertise
SMPV Limited provides senior, independent PV quality expertise where understanding, challenge and judgement matter.
BEYOND THE FINDINGS
What is your PV system really telling you?
Audits, inspections and quality activities generate findings, observations and data. But the real value comes from understanding what they may be telling you about the wider system.
Beyond the Findings explores PV risk, oversight, inspection readiness and quality through a different lens, helping PV leaders look beyond individual findings and focus attention where it matters.
Testimonials
