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Pharmacovigilance & Quality Solutions That Scale With You

EMA, MHRA & FDA aligned quality strategies supporting patient safety; from inspection readiness to global governance

Pharmacovigilance & Quality Solutions That Scale With You

EMA, MHRA & FDA aligned quality strategies supporting patient safety; from inspection readiness to global governance

WELCOME TO SMPV Limited

At SMPV Limited, our mission is clear: to support patient safety by helping leaders implement robust quality systems that drive sustainable compliance.

We partner with pharmaceutical and biotechnology companies through our Plug-in Strategy, modular, scalable quality support that integrates seamlessly into your existing operations.

With over 20 years of proven experience in drug safety, clinical development, and regulatory compliance, we deliver tailored, practical solutions that embed quality into everyday processes, so you are not just audit-ready, but inspection confident.

Unlike large CROs or PV outsourcing providers, we focus exclusively on strategic compliance, not case processing or database management. Our expertise includes:

Inspection Readiness: Mock audits, gap analysis, CAPA planning
Quality Systems Design: SOP harmonisation, governance frameworks, KPI dashboards
Regulatory Strategy & Leadership Support: Interim quality leadership, risk-based oversight

Our approach is designed for small and mid-sized biopharma companies seeking confidence in their PV and QA systems while keeping patient safety at the heart of every decision.

Explore our services and discover how SMPV Limited can plug into your team to strengthen compliance and quality, every step of the way.

Schedule a Consultation

Choose the tier that fits your compliance journey:

Tier 1: Inspection Readiness Sprint

Rapid confidence for first inspections. Includes gap analysis, governance review, inspection coaching, and a 90-day roadmap.

Start Your Sprint

Tier 2: Governance & Oversight Accelerator

Scale governance globally with frameworks, vendor oversight strategy, KPI sets, and mock reviews.

Scale Governance

Tier 3: Quarterly Readiness Leadership

Ongoing senior QA/PV leadership without full-time headcount. Quarterly health checks, inspection drills, and executive advisory to help you build a strong and productive workforce.

join the programme

Technical Highlights for PV & QA Professionals

· Risk-ranked gap analysis tied to MAH obligations

· Governance frameworks with RACI and escalation pathways

· Vendor oversight strategy with risk scoring and audit cadence

· KPI development and measurement strategy

· PV QMS implementation aligned to GVP modules

TESTIMONIALS

“I have had the pleasure of working with Stephanie as part of our PV inspection readiness activities. Stephanie’s ability to support the development of the framework for our PV inspection readiness program was instrumental in the successful outcome of the PV inspections which followed. Her extensive knowledge of the PV HA regulations and QMS are winning qualities any company would greatly benefit from.”

Head of PVQA Inspection Readiness, Pharma Company

“Very happy with the PV Audit services provided by Stephanie. A pleasure to work with.”

Head of R&D Quality and Risk Management, Pharma company

Pharmacovigilance & Quality Solutions That Scale With You

EMA, MHRA & FDA aligned quality strategies supporting patient safety; from inspection readiness to global governance

Pharmacovigilance & Quality Solutions That Scale With You

EMA, MHRA & FDA aligned quality strategies supporting patient safety; from inspection readiness to global governance

WELCOME TO SMPV Limited

PLUG-IN STRATEGY – MODULAR COMPLIANCE SOLUTIONS

Choose the tier that fits your compliance journey:

Tier 1: Inspection Readiness Sprint

Tier 2: Governance & Oversight Accelerator

Tier 3: Quarterly Readiness Leadership

Technical Highlights for PV & QA Professionals

TESTIMONIALS

CONTACT US

CONTACT US

SMPV Limited

Pharmacovigilance & Quality Solutions That Scale With You

EMA, MHRA & FDA aligned quality strategies supporting patient safety; from inspection readiness to global governance

Pharmacovigilance & Quality Solutions That Scale With You

EMA, MHRA & FDA aligned quality strategies supporting patient safety; from inspection readiness to global governance

WELCOME TO SMPV Limited

PLUG-IN STRATEGY – MODULAR COMPLIANCE SOLUTIONS

Choose the tier that fits your compliance journey:

Tier 1: Inspection Readiness Sprint

Tier 2: Governance & Oversight Accelerator

Tier 3: Quarterly Readiness Leadership

Technical Highlights for PV & QA Professionals

TESTIMONIALS

CONTACT US

CONTACT US

SMPV Limited

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