Pharmacovigilance Compliance Self-Assessment Platform. PV CompliSure is an AI-powered pharmacovigilance self-assessment tool for Marketing Authorisation Holders (MAHs) operating in Africa.
It allows organisations to objectively evaluate their pharmacovigilance system against the regulatory requirements of multiple African countries, identify compliance risks before inspections occur, and convert policy changes into clear, actionable compliance obligations.
The compliance blind spot we solve
Pharmacovigilance compliance is not a once-a-year event. It is a daily discipline. But most organisations discover they have a problem only when the auditor asks for a document that was never signed, a training record that was never logged, or a regulatory obligation that changed six months ago without anyone noticing.
- Compliance gaps discovered at inspection — not before
- Regulatory changes missed because no one was monitoring
- Training records scattered across spreadsheets and email threads
- No single view of your organisation's inspection readiness
What PV CompliSure does
PV CompliSure eliminates regulatory blind spots and keeps MAHs continuously inspection-ready — across multiple African jurisdictions simultaneously.
Multi-Country Compliance Self-Assessment
Evaluate your pharmacovigilance system against the regulatory requirements of multiple African jurisdictions simultaneously. Identify gaps, quantify risk, and generate a prioritised remediation plan broken down by country, GVP module, and functional area.
Multi-Jurisdiction
AI-Powered Regulatory Intelligence
PV CompliSure continuously tracks regulatory developments across African NRAs. It interprets their impact on your business and converts policy changes into clear, actionable compliance obligations — so you know the moment something affects your PV system.
AI-PoweredGap Analysis & CAPA Tracking
Identified gaps are logged with severity ratings, responsible owners, and remediation deadlines. Track CAPA closure status and supporting evidence in one place — with complete audit trail for regulators.
CAPA ManagementInspection Readiness Dashboard
A real-time view of your organisation's inspection readiness, including documents, training records, compliance scores, and open findings — available on demand, not just the week before an inspection.
Real-Time DashboardWhat CompliSure delivers
Organisations using PV CompliSure shift from discovering compliance gaps at inspection to maintaining continuous, documented, and demonstrable inspection readiness.
Risk Scoring
Every assessment generates a compliance risk score by country, GVP module, and functional area — with progress tracked over time.
Regulatory Intelligence
Policy changes across African NRAs are automatically interpreted and converted into actionable obligations — delivered when they happen.
Integrated Ecosystem
Connected to IntraVigi Safety Database and IntraHub LMS — case data and training completions feed automatically into compliance records.
- Continuous Monitoring
- Evidence-Backed Audit Trail
- Multi-Country Coverage
Who PV CompliSure serves
PV CompliSure is designed for the professionals who own pharmacovigilance compliance responsibility — at both operational and strategic levels.
Compliance & Quality Teams
Quality Assurance and Compliance leads, Qualified Persons for Pharmacovigilance (QPPVs), PV System Owners, and internal and external PV auditors who need an objective, continuously updated view of their compliance posture.
Regulatory & Senior Leadership
Regulatory Affairs Directors and senior leadership who need board-level visibility into compliance risk — with data that demonstrates continuous improvement to regulators and internal stakeholders.
How to get started
Book a demo and see how PV CompliSure scores your current pharmacovigilance system against the regulators that matter most to your business.
Book a Demo
We run PV CompliSure against your current PV system profile and show you your compliance risk scores across your target African markets.
Configure & Connect
We configure your CompliSure instance for your product portfolio and markets, and connect it to your IntraVigi and IntraHub LMS data.
Continuous Compliance Monitoring
Your dashboard is live. Compliance scores update as activities are completed. Regulatory changes trigger automatic obligations. Your inspection readiness is visible on demand.