Your pharmacovigilance system, run by the team that knows what EDA is looking for.
EMCO Egypt manages pharmacovigilance for 35+ pharma companies and 300+ products in Egypt and Iraq. We have been through the audit cycle on our own PSMF. Your PV system is built around that knowledge.
35+
Active PV Clients
300+
Products Under Management
PSMF Audited
Our own system, formally certified
Egypt & Iraq
100% EDA-PVGA Compliant
Manual pharmacovigilance is a liability. The inspection will find it.
EDA pharmacovigilance inspections are increasing in frequency. The notification can arrive with two weeks' notice. That is not enough time to build a PV system — but it is enough time to prepare one that already exists.
PSMF Management
We build your Pharmacovigilance System Master File from scratch or take over an existing PSMF, align it with EDA/PVGA requirements and ICH E2E guidelines, and maintain it continuously as your product portfolio changes. Your PSMF is always current, always inspection-ready.
Our own PSMF has been formally audited. We apply the same standard to every client system.
Learn more about PSMFs
ICSR Processing & EDA/PVGA Submission
Every adverse event your company receives enters our ICSR workflow — intake, triage, medical assessment, narrative writing, and submission within the 15-day expedited window for serious cases. We use PV Radar, our purpose-built pharmacovigilance software, to automate the workflow and maintain the full audit trail.
We also manage Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and all aggregate reporting submissions to EDA on schedule.
Signal Detection & Literature Monitoring
Beyond case processing, we run systematic signal detection — reviewing your ICSR database, literature data (via PVLR, our automated literature review tool), and spontaneous reporting data for emerging safety signals. This is active surveillance, not just case filing.
Literature monitoring is conducted at defined, documented intervals and integrated into the signal detection and PSUR preparation processes — as required under GVP Module VI.
Outsourced QPPV Coverage
For companies without an in-house qualified QPPV, EMCO Egypt provides outsourced Qualified Person for Pharmacovigilance (QPPV) coverage — a qualified pharmacovigilance professional named in your PSMF, responsible for the oversight and integrity of your PV system, and available for regulatory contact with EDA.
We also participate in EDA pharmacovigilance inspections for clients on our outsourcing service — because we have been running the system and know its contents in detail.
QPPV TrainingPowered by PV Radar — built for EDA and PVGA requirements.
Every client on our PV outsourcing service operates through PV Radar — our purpose-built pharmacovigilance software. Complete audit trail, automated ICSR workflows, E2B compliant, Arabic and English interface.
ICSR Management
- Automated ICSR workflow from intake to submission
- E2B (R2) compliant XML output
- Duplication detection
- Follow-up and null case support
- Online case submission by HCPs
PV Process Management
- PSMF management and documentation
- PSUR preparation and tracking
- Risk Management File (RMF) management
- PV calendar and deadline reminders
- Signal detection module
Technical Infrastructure
- Full audit trail with auto-scaling
- 24/7 monitoring and automated alerts
- Secured private network
- Disaster recovery and full data export
- Arabic and English interface
Start with an assessment. Know exactly where your PV system stands.
A 30-minute conversation with the EMCO Egypt pharmacovigilance team identifies the gaps in your current system and gives you a clear picture of what outsourcing your PV function to EMCO would involve.
Request a PV Assessment See PV Radar