Local representation, inspection readiness, and faster approvals — for pharmaceutical, biotech, vaccine, and medical device companies in Nigeria and West Africa.
PV system setup & SOPs
SAE / SUSAR reporting
Safety documentation & regulatory filing
Local QPPV representation
Signal detection & PSUR / PBRER
Most pharmacovigilance providers understand global regulations. Few understand local implementation. MedNova combines both — international standards, delivered with the operational knowledge to work through fragmented reporting systems, evolving regulations, multiple languages, and varied care settings.
Supported acrossThis is now a regulatory obligation. Under NAFDAC's QPPV guidelines (effective October 2024), every Marketing Authorization Holder must maintain a resident QPPV in Nigeria — permanently, continuously, and with backup provisions in place. MedNova provides exactly this.
Request a QPPV proposalFor Marketing Authorization Holders, this is the obligation that never closes: a responsible safety contact, current aggregate reports, and continuous surveillance. MedNova carries it as a monthly retainer, so your compliance position holds between submissions — not just at them.
Bringing products to market in Nigeria — and keeping them there. QPPV clients get one partner for both safety and registration.
Six core disciplines — from a single case report to a national regulatory system.
Technology enabled — we use proprietary digital tools to support safety operations, with every output checked and finalized by trained safety staff before use.
Individual and aggregate safety reporting handled to global submission standards.
Individual and aggregate safety reporting handled to global submission standards.
Turning safety data into decisions, not just reports.
Integrated directly with MedNova Clinical Research.
Local QPPV representation and full PV system build-out.
Continuous monitoring beyond the case report.
Building safety competency inside your organization, not just around it.
Three ways to work with MedNova.
For companies entering the Nigerian market.
Best for: Companies launching products in Nigeria.
For sponsors running studies.
Best for: Sponsors running Phase II–IV clinical studies.
For organizations that want MedNova to run drug safety end to end.
Best for: Organizations ready to fully outsource pharmacovigilance.
Drug safety obligations look different across these groups — the underlying discipline doesn't.
A practical self-assessment guide for Marketing Authorization Holders — 10 sections covering governance, safety reporting, signal detection, and inspection readiness against current NAFDAC expectations.
Answer six questions to get an instant readiness score against NAFDAC's QPPV requirements — a real assessment tool, not a demo.
Whether you need full-service case processing, clinical trial safety oversight, or local pharmacovigilance support in Nigeria, MedNova provides scalable solutions tailored to your program.