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SMPV Limited
  • Home
  • About
  • Services
  • Pharmacovigilance
  • Resources
  • Speaking and Events
  • FAQ
  • Contact Us

Inspection‑Ready Pharmacovigilance Services

Focused support to strengthen pharmacovigilance quality systems so inspection readiness becomes predictable, defensible, and sustainable.

Which service is right for you?

An inspection has been announced or is imminent

  • Use Stress‑Test, followed by Strengthen, to challenge and stabilise the system under inspection scrutiny.


An inspection is likely but not yet scheduled

  • Use Clarify to identify genuine inspection exposure and avoid unnecessary preparation.


No inspection planned, but readiness feels uncertain

  • Use Clarify to understand system behaviour and prioritise targeted strengthening.

The Always-Ready PV Framework

From visibility → control → defensibility


All services are delivered through the Always‑Ready PV Framework. 

This modular approach replaces fragmented audits and one‑off inspection activities with targeted system‑level work that improves control and reduces repeat disruption.

Find out more

Make the real system visible.

Prove the system under real scrutiny.

Make the real system visible.

Use this when inspection readiness feels uncertain and you need clarity before committing to broader work.


Focus areas include:

  • PV system mapping and interfaces
  • Governance, ownership, and escalation clarity
  • PSMF alignment with practice
  • Identification of inspection risk areas



Outcome: 

Clear visibility of where control exists today and where inspection exposure sits.

Build predictable control.

Prove the system under real scrutiny.

Make the real system visible.

Use this when gaps are known and governance, oversight, or vendor control needs stabilisation.


Focus areas include:

  • Targeted deep dives into priority risk areas
  • Strengthening governance cadence and decision‑making
  • Vendor oversight, KPIs, and MAH control
  • SME coaching to support sustainable system operation


Outcome: 

Inspection readiness that reduces repeat disruption and reliance on fire‑drills.

Prove the system under real scrutiny.

Prove the system under real scrutiny.

Prove the system under real scrutiny.

Use this when an inspection is announced or confidence in system behaviour is required urgently.


Focus areas include:

  • End‑to‑end inspection scenario testing
  • Inspector‑style questioning and system challenge
  • PSMF and system narrative testing
  • Assessment of evidence retrieval and consistency


Outcome: 

Confidence that the system can explain itself under inspection conditions.


what this delivers in practice

·  More predictable inspection readiness

·  Clearer MAH‑side governance and oversight

·  Consistent inspection narratives across teams and vendors

·  Faster access to inspection‑ready evidence

·  Lower long‑term cost of compliance through fewer repeat preparation cycles

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WHAT MAKES US DIFFERENT?

Interaction lens

Interaction lens

Interaction lens

PV–QA–Reg–Medical–Vendors


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Governance rhythm

Interaction lens

Interaction lens

Decisions/Minutes/KPIs with narrative

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PSMF COHERENCE

Interaction lens

PSMF COHERENCE

Practice ↔ Paper


Learn More

what this is not

  • Outsourced PV, QA, case processing, or QPPV.  
  • Generic SOP packs or template‑driven remediation
  • Stand‑alone mock inspections without system improvement
  • Large programme delivery or operational takeover

READY TO ELEVATE YOUR SYSTEM?

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SMPV Limited

London, United Kingdom

Copyright © 2026 SMPV Limited - All Rights Reserved.

SMPV LIMITED is a limited company registered in England and Wales.
Registered number: 11388233
Registered office: 241 Mitcham Road, Tooting, London, England, SW17 9JQ

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Take your inspection readiness to the next level.

Complete the scorecard to assess your readiness and have an immediate feedback on areas to improve.

The Plug-In Strategy.

Compliance That Fits, Confidence That Lasts. 

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