Enterprise Pharmacovigilance Platform for Africa. IntraVigi Safety Database is a full-scale pharmacovigilance system designed to manage the complete lifecycle of drug safety operations for Marketing Authorisation Holders (MAHs) operating in regulated African markets.
It consolidates ICSR processing, pharmacovigilance documentation, regulatory submissions, and quality management into a secure, multi-tenant platform aligned with international standards and national regulatory requirements.
Why IntraVigi?
Most pharmacovigilance systems used in Africa are fragmented, manual, and poorly aligned with African regulatory realities. IntraVigi was built specifically to close this gap. With IntraVigi, organisations move from reactive compliance to controlled, traceable, regulator-ready operations.
- Built from the ground up for African regulatory requirements
- Replaces spreadsheets, email chains, and disconnected paper files
- Aligned with NAFDAC, WHO, EMA, ICH E2B(R3), and FDA standards
- Multi-tenant enterprise architecture with full audit logging
Core functional capabilities
IntraVigi Safety Database covers every major pharmacovigilance function in a single, integrated platform — eliminating the need for multiple disconnected systems.
Complete ICSR & Case Management
Structured CIOMS and ICH E2B(R3) compliant case intake. Multi-source ingestion from manual entry, IntraVigi App, AI chatbot, email, and third-party integrations. Enforced workflow: Data Entry → Quality Review → Medical Review → Regulatory Submission. Integrated duplicate detection, full audit trails, and submission history.
E2B(R3) Compliant
PV Document & QMS Management
IntraVigi treats pharmacovigilance documentation as a regulated quality system. Full PSMF lifecycle management, Risk Management Plans, PSUR/PBRER management, SOP repository, controlled document versioning, review and approval workflows, and change control with audit readiness.
QMS IntegratedRegulatory Compliance & Submissions
E2B(R3) and CIOMS I exports, expedited and periodic reporting with deadline tracking, inspection readiness dashboards, authority communication log, and compliance calendar with automated alerts.
Submission ReadyExecutive Dashboards & Analytics
Real-time case processing metrics, compliance and risk monitoring, submission performance tracking, and inspection readiness status — all in one dashboard view for PV managers and executives.
Real-Time AnalyticsWhat IntraVigi delivers
Organisations that move to IntraVigi shift from reactive, fragmented compliance to a controlled, inspection-ready pharmacovigilance operation.
Inspection Readiness
Always-on dashboards show your real-time compliance posture and open findings — no last-minute scramble before an audit.
Zero Double Entry
Reports from the IntraVigi Reporting App flow directly into the case management queue — no manual data transfers, no information loss.
Full Audit Trail
Every case action, document change, and submission is logged, timestamped, and accessible — providing complete traceability for regulators.
- E2B(R3) & CIOMS Compliant
- Multi-Tenant Architecture
- Enterprise-Grade Encryption
Deployment options & who it serves
IntraVigi is available in multiple deployment configurations to match your organisation's infrastructure requirements and multi-country operating model.
Deployment Options
Cloud-hosted (managed by IntraHub Africa), private cloud on your own infrastructure, or hybrid setups for multi-country operations — whichever fits your security and IT requirements.
Who IntraVigi Serves
MAHs with products registered in African markets, CROs running clinical trials or PV operations, local manufacturers building a compliant PV function, and multinational companies needing a regional database for African operations.
Getting started with IntraVigi
From demo to deployment, we guide your organisation through every step of the onboarding process.
Request a Demo
Book a 30-minute demo with one of our pharmacovigilance specialists. See IntraVigi configured for your product types and regulatory markets.
Configuration & Data Migration
We configure your tenant, import existing case data, set up your workflow rules, user roles, and regulatory submission connections.
Go-Live & Ongoing Support
Your team goes live with full training and documentation. We provide ongoing technical support, regulatory updates, and platform enhancements.