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PLUG-IN STRATEGY

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PLUG-IN STRATEGY

OUR SERVICES

Flexible, modular pharmacovigilance and quality solutions tailored to your needs.

SMPV Limited provides flexible, modular pharmacovigilance and quality solutions for small and mid‑sized biopharma. We specialise in strategic PV compliance, helping you achieve inspection readiness, strengthen governance, and maintain sustainable, defensible quality systems, without full outsourcing.


The Plug‑In Strategy

A three‑tier modular compliance framework tailored to your PV maturity. Choose the tier that fits your needs—whether you need fast inspection readiness, improved governance, or ongoing leadership support.

Find out more

FULL-SERVICES CONSULTING

Pharmacovigilance audits and inspection readiness planning

Quality Management System (QMS) design, optimisation, and implementation

Quality Management System (QMS) design, optimisation, and implementation

Quality Management System (QMS) design, optimisation, and implementation

Quality Management System (QMS) design, optimisation, and implementation

Quality Management System (QMS) design, optimisation, and implementation

Risk management and CAPA strategy

Training and coaching for PV and QA teams

Training and coaching for PV and QA teams




Training and coaching for PV and QA teams

Training and coaching for PV and QA teams

Training and coaching for PV and QA teams



PLUG-IN STRATEGY

Tier 1: Inspection Readiness Sprint

Fast‑track inspection readiness through a deep gap review, inspection rehearsal, and a focused 90‑day action plan.

Includes:

  • Comprehensive PV system gap analysis mapped to MAH obligations
  • Governance review for alignment
  • Inspection coaching with real‑world Q&A and front/back‑room simulation
  • 90‑day readiness roadmap prioritised by risk
  • Vendor oversight touchpoint for critical interfaces

Deliverables:

  • PV System Gap Report
  • Inspection Readiness Checklist
  • CAPA Plan Starter 
  • Inspection Coaching Deck
  • Mock Inspection Report

Timeline:
2‑week assessment → 6‑week implementation → 90‑day roadmap execution


Start Your Sprint

Tier 2: Governance & Oversight Accelerator

Build structured, risk‑based PV governance and vendor oversight that is consistent, controlled, and inspection‑ready.

Includes:

  • Governance framework with RACIs and escalation pathways
  • Vendor oversight strategy with risk scoring and audit/assessment cadence
  • KPI development and measurement strategy
  • Governance Effectiveness Review

Deliverables:

  • Governance Playbook
  • Vendor Oversight Strategy & Calendar
  • Vendor Scorecard Template
  • KPI Library & Dashboard Specification
  • Governance Effectiveness Review Report

Timeline:
4‑week design → 8‑week rollout → quarterly review

Scale Governance

Tier 3: Quarterly Readiness Leadership

Ongoing senior PV/QA leadership to maintain inspection readiness, visibility, and control—without adding headcount.

Includes:

  • Quarterly compliance health checks
  • Inspection drills (as needed)
  • Audit & CAPA oversight (coaching review, not execution)
  • Executive advisory support

Deliverables:

  • Quarterly Compliance Health Report 
  • Inspection Drill Pack 
  • Audit & CAPA Oversight Brief
  • Executive Advisory Brief

Timeline:
Ongoing quarterly engagement

join the programme

AD-HOC SERVICES

Need a lighter engagement? We offer ad hoc consulting for targeted needs such as audits, SOP reviews, compliance health checks, or vendor oversight touchpoint, ideal for organisations seeking quick, expert input without committing to a full program.

WHAT YOU GET

  • Expertise: 20+ years in PV Quality & inspection support
  • Flexibility: Short-term sprints or interim leadership
  • Impact: Reduced inspection findings, accelerated CAPA closure, stronger governance

Ready to strengthen your compliance

WHY CHOOSE SMPV Limited?

  • We do not dilute focus with case processing or database hosting.
  • We specialise in quality maturity, the foundation of sustainable compliance.
  • We plug in without disruption, working alongside your PV operations team.

Ready to strengthen your compliance
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SMPV Limited

London, United Kingdom

Copyright © 2021 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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The Plug-In Strategy.

Compliance That Fits, Confidence That Lasts. 

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