Smpv Limited

What Smpv Limited does

SMPV Limited is a UK-based pharmacovigilance (PV) quality consulting firm founded in 2018 and headquartered in London. The company delivers senior-level advisory services to pharmaceutical and biotechnology organisations, focused on PV inspection readiness, PSMF coherence, governance stabilisation, MAH oversight, and vendor control. Its core IP is the "Always-Ready PV Framework," a structured methodology organised into three branded service modules — Clarify (diagnostic assessment of system architecture and PSMF alignment), Strengthen (governance cadence, decision-making, vendor oversight, and SME coaching), and Stress-Test (inspector-style scenario testing). SMPV is explicit about what it does not do: it does not provide outsourced PV operations, generic SOP packs, or standalone mock inspections.

The firm is founder-led by Managing Director Stephanie Martin, a senior PVQA specialist, with no other named management and a stated "no junior auditors" positioning. The operating model is sales-led, professional services delivery: engagements begin with a 30-minute readiness call via Calendly, then proceed as modular projects typically starting at 2-4 weeks and extending onward, with quote-based pricing. The company markets primarily through thought leadership — podcast appearances (The Pharmacovigilance Podcast, The Vigilance Unplugged Podcast), industry conference speaking (ISoP, ARCS, RQA, PHARMACOVIGILANCE WORLD), LinkedIn, and a website-hosted Inspection Readiness Quiz. It is registered as a private limited company in England and Wales (company number 11388233), with no external funding, parent company, subsidiaries, or M&A activity recorded in the available data.

Name

Smpv Limited

Legal name

SMPV Limited

Website

https://smpvlimited.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

SMPV Limited is a UK-based pharmacovigilance quality consulting firm that helps pharmaceutical and biotechnology organisations achieve sustainable inspection readiness via its Always-Ready PV Framework, serving PV leaders through senior-led advisory engagements.

Ownership category

akta.pro rank

Product category

Pharmacovigilance Quality Consulting

NAICS

Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

akta.pro secondary industry

Medical Review & Pharmacovigilance Quality (PV QA/Audits/SOPs) (HLAGALAH)

Keywords

• Pharmacovigilance consulting
• Inspection readiness
• PV quality systems
• Regulatory compliance consulting
• PV system governance

Headquarters

HQ city

City Of London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmacovigilance Consulting Services: SMPV Limited generates revenue through professional consulting engagements focused on pharmacovigilance inspection readiness, governance, MAH oversight, and system control. Services are delivered through their Always-Ready PV Framework with modular offerings (Clarify, Strengthen, Stress-Test) that can be packaged for short-term or extended engagements. The company works with pharmaceutical and biotech organisations on a project basis, with engagements starting from 2-4 weeks onwards.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

SMPV Limited provides senior pharmacovigilance and quality consulting services to pharmaceutical and biotechnology organisations. The company helps clients achieve sustainable, defensible inspection readiness through its proprietary Always-Ready PV Framework, delivering modular engagements spanning PV system diagnostics, governance strengthening, and inspection scenario testing across UK/EU/US regulatory environments (EMA, MHRA, FDA).

Product overview

SMPV Limited is a pharmacovigilance consulting firm offering a unified service methodology called the Always-Ready PV Framework. The framework comprises three interconnected service modules—Clarify (diagnostic assessment), Strengthen (governance improvements), and Stress-Test (inspection simulation)—alongside supporting offerings including workshops, coaching, and an online readiness quiz. Rather than a software product, SMPV delivers hands-on consulting engagements aimed at helping pharmaceutical and biotech organizations achieve sustainable, defensible inspection readiness.

Differentiator

Problem solved

Functional benefit

Brands

• Always-Ready PV Framework: A structured approach to pharmacovigilance system governance designed to ensure year-round inspection readiness through clarity, control, and confidence.

Products and services

• Always-Ready PV Framework A structured methodology for pharmacovigilance system governance designed to ensure year-round inspection readiness through clarity, control, and confidence. Includes modules for system mapping, governance stabilization, and inspection scenario testing. Targeted at PV leaders in pharmaceutical and biotech organisations.
• Clarify Service Diagnostic service module providing visibility into PV system architecture, governance ownership, escalation clarity, and PSMF alignment. Identifies inspection risk areas and delivers clear understanding of where control exists and where exposure sits. Targeted at PV leaders responsible for inspection outcomes.
• Strengthen Service Service module delivering targeted improvements focused on governance cadence, decision-making, vendor oversight, KPIs, and MAH control. Includes SME coaching to support sustainable system operation and reduce reliance on fire-drills. Targeted at lean and scaling pharmaceutical and biotech organisations.
• Stress-Test Service Service module providing inspection scenario testing including inspector-style questioning, system challenge, PSMF and narrative testing, and evidence retrieval assessment. Provides confidence that the PV system can explain itself under actual inspection conditions. Targeted at organisations preparing for an upcoming inspection.
• Inspection Readiness Workshop Interactive workshop for PV leaders to understand inspection expectations, common failure patterns, and practical approaches to building defensible compliance systems. Targeted at pharmacovigilance leaders in pharmaceutical and biotech organisations.

Quantifiable outcome

• Engagements starting from 2-4 weeks onwards

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Parexel International: Global CRO with regulatory and pharmacovigilance capabilities including inspection support and PV audits — competes for the same pharma/biotech inspection-readiness budgets from a broader service base.
• Worldwide Clinical Trials: Mid-tier global CRO with PV, regulatory and quality services for pharma/biotech — overlaps on PV system design, MAH oversight, and inspection-readiness support.
• IQVIA: Largest global CRO now owning PrimeVigilance; offers enterprise-scale PV, QPPV, and inspection-readiness services as part of a much wider clinical and real-world evidence portfolio — competes for the same MAH inspection-readiness wallet.
• ICON plc: Global CRO with a PV and regulatory affairs practice serving large pharma — broader service portfolio but directly competes for inspection-readiness and PV quality mandates.

Direct peers

• Arriello: PV, regulatory affairs and quality consulting firm serving pharma/biotech with inspection-readiness, PV system design, and remediation support — overlapping service catalogue and customer segments.
• NDA Group: Drug development consultancy with a strong PV and regulatory practice offering QPPV, audit, and inspection-readiness services to pharma/biotech MAHs — directly comparable in PV quality and compliance scope.
• PharSafer: Pharmacovigilance and risk management consultancy delivering QPPV, audit, inspection support, and PV quality services to small and mid-sized pharma — comparable niche focus and target buyer profile to SMPV.
• PrimeVigilance: Specialised pharmacovigilance service provider offering QPPV support, PSMF management, PV audits, and inspection-readiness services to pharma/biotech MAHs — the closest direct peer in scope, customer base, and service mix.
• ELIQUENT Life Sciences: Life sciences regulatory, PV and quality consultancy serving pharma/biotech — peer in PV inspection readiness and MAH oversight, and already adjacent to SMPV through The Vigilance Unplugged Podcast.

Emerging players

• Pharmathen / other PV boutiques: Smaller PV/regulatory consultancies serving lean pharma/biotech — partial overlap in inspection-readency, PSMF and QPPV services but typically with narrower geographic or therapeutic scope.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/smpv-limited

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Smpv Limited