End-to-end pharmacovigilance support for marketing authorisation holders, pharmaceutical manufacturers, and CROs operating across Africa. From PV system design to regulatory submissions, we manage the complete drug safety lifecycle so you can focus on bringing medicines to market.
Our services are aligned with NAFDAC, WHO, EMA, ICH, and FDA requirements. Whether you are building a PV function from scratch or strengthening an existing one, IntraHub Africa delivers a system that is compliant, efficient, and inspection-ready.
What our pharmacovigilance services deliver
Our PV capabilities cover every aspect of the drug safety lifecycle — from initial system design through ongoing signal detection and regulatory reporting.
Core capabilities include:
- PV system setup, gap analysis, SOPs, PSMF, and QMS
- Full ICSR lifecycle — intake, MedDRA coding, medical review, E2B(R3) submission
- Signal detection (PRR, ROR, BCPNN, MGPS) and risk management
- Aggregate reporting: PSURs, PBRERs, DSURs, PADERs
- QPPV services with 24/7 availability
- Audit and inspection readiness support
Our pharmacovigilance capabilities
We provide the full spectrum of pharmacovigilance services — either as a complete outsourced PV function or as targeted support for specific areas of your operation.
ICSR Case Management
Structured case intake via CIOMS and ICH E2B(R3), multi-source ingestion, enforced workflow (Data Entry → Quality Review → Medical Review → Regulatory Submission), MedDRA coding, duplicate detection, follow-up management, and full audit trail. Powered by IntraVigi Safety Database.
Regulatory Submissions & Expedited Reporting
Timely submission of E2B(R3) and CIOMS I reports to NAFDAC, WHO-UMC VigiBase, EMA EudraVigilance, FDA FAERS, and other African regulatory authorities — within all expedited (15-day) and periodic reporting deadlines. Includes acknowledgement tracking and compliance calendar.
Signal Detection & Risk Management
Quantitative signal detection (PRR, ROR, BCPNN, MGPS) and qualitative signal evaluation, Risk Management Plan (RMP) development and maintenance, risk minimisation measures and effectiveness evaluation, and benefit-risk assessment support.
Aggregate Safety Reporting & Medical Writing
PSURs, PBRERs, DSURs, PADERs, Addendum Reports, ad hoc safety summaries, line listings, and summary tabulations — prepared by our pharmacovigilance and medical writing specialists.
Literature Monitoring
Systematic screening of global indexed literature (PubMed, Embase) and local/regional non-indexed sources. Relevant article retrieval, assessment, ICSR extraction, and full compliance with GVP Module VI requirements.
QPPV & Deputy QPPV Services
Experienced QPPV and Deputy QPPV professionals providing local QPPV appointment, PSMF oversight, 24/7 availability for urgent safety matters, regulatory liaison, and inspection support.
Audit & Inspection Readiness
PV system audit and self-inspection, inspection readiness assessment and mock inspections, gap analysis and remediation planning, CAPA management, and vendor/partner PV audits.
How we engage
We start by understanding your products, markets, and current PV maturity — then build or optimise your system around exactly what you need, with clear timelines and no surprises.
Free Consultation & Needs Assessment
We review your existing PV systems, SOPs, and compliance framework — identifying gaps, quantifying risk, and documenting what needs to change.
Tailored Roadmap & Scope Agreement
A clear plan with timelines, deliverables, and regulatory milestones. We define scope together — no jargon, no surprises.
Implementation & Ongoing Support
We build or optimise your PV system, deploy our technology, train your team, and remain with you for ongoing monitoring, reporting, and audit readiness.
Who we serve
Our pharmacovigilance services are designed for the full range of pharmaceutical market participants operating across Africa.
We work with:
- Marketing Authorisation Holders (MAHs) with products registered in African markets
- Multinational pharmaceutical companies requiring local PV representation
- Local and regional pharmaceutical manufacturers scaling up their PV function
- Contract Research Organisations (CROs) running clinical trials or post-marketing PV
- Generic and biosimilar companies entering regulated African markets