Adverse Event Reporting
Timely collection, assessment, and reporting of adverse events to regulatory authorities. We ensure compliance with local and international reporting timelines.
Pharmacovigilance Services
Ensure patient safety and regulatory compliance with our comprehensive pharmacovigilance solutions. Expert adverse event monitoring, reporting, and risk management across Africa.
Service 07 / 0707What we deliver
Comprehensive Safety Monitoring
Protecting patients through vigilant safety surveillance
Safety Database Management
Maintain comprehensive safety databases with proper case processing, coding, and narrative writing. Full compliance with ICH E2B standards.
PSUR/PBRER Preparation
Expert preparation of Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports for regulatory submissions across African markets.
Risk Management Plans
Development and maintenance of comprehensive Risk Management Plans (RMPs) tailored to African regulatory requirements and patient populations.
Signal Detection
Proactive identification and evaluation of potential safety signals through systematic data analysis and literature monitoring.
PV Training & SOPs
Comprehensive pharmacovigilance training programs and development of Standard Operating Procedures for your local teams.
Why ECP
Local expertise. Global standards.
A consortium of professionals with over 15 years of experience and in-depth knowledge of African Medicines Regulatory Authorities and the standards they apply.
- Nairobi-based specialists with regional reach across 25+ countries
- A multidisciplinary team covering regulatory, clinical, safety and quality
- A track record with leading pharmaceutical organisations
How we work
Our Pharmacovigilance Process
A systematic approach to patient safety
1
Case Receipt
Collect adverse event reports from all sources
2
Case Processing
Assess, code, and document adverse events
3
Medical Review
Expert medical assessment and causality evaluation
4
Regulatory Reporting
Submit reports to authorities within required timelines
5
Ongoing Monitoring
Continuous safety surveillance and signal detection
Continue exploring
Other ECP services.
01
Strategic Regulatory Intelligence
Stay ahead of evolving regulatory environments in African markets with strategic intelligence.
02Regulatory Affairs
Comprehensive regulatory affairs management, from new product authorisations to lifecycle management.
03Clinical Research
Clinical trial support, site selection, regulatory approvals and pharmacovigilance services.
Begin
Prioritize Patient Safety
Partner with ECP for expert pharmacovigilance services across Africa. Tell us about your product and target markets and we will respond with a clear next step.