Skip to Content

Safety Intelligence That Protects Patients

Egypt's full-stack pharmaceutical regulatory company — pharmacovigilance outsourcing, drug registration, regulatory training, and purpose-built RegTech software for Egypt, the Gulf, Iraq, and Africa.

Book a Discovery Call   See Our Services

10+ Years

Regulatory Practice

35+ Companies

Active Clients

300+ Products

Under Management

EMA R2 & R3

Validated

4 Markets

Egypt · Iraq · Gulf · Africa

4 Software

Products Built In-House

Four capabilities. One team. Every market.

EMCO Egypt is the only Egyptian regulatory firm combining full-service outsourcing, proprietary software, regulatory training, and Africa & Gulf market access.

Pharmacovigilance & Registration

We run your pharmacovigilance system and manage drug registration for Egypt, the Gulf, and Africa — as your embedded regulatory team, not a vendor.

PV Services   Registration
RegTech Software

PV Radar, eCTD Radar, PVLR, and Reg Radar — four purpose-built software products designed for EDA, PVGA, and MENA regulatory requirements. Built in-house.

See Software
Regulatory Training

QPPV, eCTD, GMP, and PV Radar training — delivered by active regulatory practitioners. When our trainer explains a PSMF audit, it is because they have managed one.

View Training
Africa & Gulf Market Access

Pharmagit for African registration (12+ markets). eCTD Radar — EMA R2 and R3 validated — for Gulf submissions. You registered in Egypt. Now grow beyond it.

Market Access

Your PV system is our operational responsibility.

EMCO Egypt manages pharmacovigilance for 35+ pharma companies and 300+ products in Egypt and Iraq. We maintain your PSMF, process your ICSRs within the 15-day expedited window, and keep your system audit-ready at all times — not just before an inspection.

Our own PSMF has been formally audited. We apply the same standard to every client system we manage.

PV Outsourcing   QPPV Training
Pharmacovigilance outsourcing EMCO Egypt
PV Radar eCTD Radar regulatory software

We built the software because the market needed it.

PV Radar automates ICSR workflows for EDA and PVGA requirements. eCTD Radar generates XML backbones for eCTD v4 and v3.2 — EMA R2 and R3 validated. PVLR automates literature review under GVP Module VI. Reg Radar tracks registration milestones across Egypt, Gulf, and Africa.

These are not white-labelled global tools. They were built by EMCO Egypt's software department — the same team running our outsourcing operations.

PV Radar   eCTD Radar   All Software

Most regulatory firms do one thing. We built the full stack.

Validated Where It Counts

eCTD Radar holds EMA R2 and R3 validation. Our own PSMF has been formally audited. Credentials that matter in a regulatory context.

Built for Egypt and MENA

Every product and service was designed for EDA, PVGA, and the specific requirements of Egyptian, Gulf, Iraqi, and African regulatory environments.

Services + Software + Training

The same expertise runs through all three. No hand-offs between the regulatory team, the software team, and the trainers.

Embedded Partner

We integrate into your regulatory operations as a long-term partner — responsible for outcomes, not just deliverables. Your compliance is our operational responsibility.

ACTIVE MARKETS

Egypt – EDA / PVGA Compliant  |  Iraq – Full PV Coverage  |  Gulf – eCTD Ready  |  Africa – Pharmagit

QPPV pharmacovigilance training Egypt

QPPV & PV Training

Egyptian GVP requirements, PSMF management, ICSR workflows, and EDA inspection readiness. Delivered by active pharmacovigilance practitioners. Arabic and English.

Learn more
eCTD training regulatory dossier

eCTD Training

eCTD v4 and v3.2 structure, XML backbone, and hands-on use of eCTD Radar — our EMA R2 and R3 validated dossier software. For regulatory affairs professionals building or submitting eCTD dossiers.

Learn more
PV Radar software training

GMP & PV Radar Training

Good Manufacturing Practice training for QA teams and regulatory professionals, plus dedicated PV Radar software training for organisations using the platform directly.

All Training

Regulatory Insights from EMCO Egypt

Expert perspectives on pharmacovigilance, eCTD, drug registration, and regulatory software — from the team that operates these systems every day.

Read Our Blog

Your regulatory operation should be a competitive advantage, not a liability.

Whether you need to outsource your pharmacovigilance, register in a new market, implement regulatory software, or train your team — the conversation starts with 30 minutes.

Book a Discovery Call