From EDA Registration to Gulf eCTD to African Markets — One Team.
EMCO Egypt manages drug registration for Egypt (EDA), Gulf countries (SFDA, MOH/DHA, GCC), and Africa (via Pharmagit) — using eCTD Radar, our EMA R2 and R3 validated dossier software.
Core Registration & Outsourcing Services
Pharmacovigilance Outsourcing
PSMF management, ICSR processing within the 15-day expedited window, EDA/PVGA submissions, signal detection, literature monitoring, and outsourced QPPV coverage. 35+ active clients, 300+ products.
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eCTD Outsourcing
Full eCTD dossier compilation and submission for SFDA, EMA, EDA, and GCC authorities using eCTD Radar — EMA R2 and R3 validated. Lifecycle and sequence management. Variation and renewal support.
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EDA Drug Registration
Full CTD dossier preparation and submission for Egyptian EDA registration. Arabic labelling, Module 1–5, bioequivalence coordination, response to EDA queries, renewal and variation management.
Request assessmentAfrica Registration — Pharmagit
EMCO Egypt built Pharmagit specifically to make African pharmaceutical registration structured and manageable. It provides country-specific registration pathways for 12+ African markets, dossier management, and real-time submission tracking.
Egypt is a reference agency for several African regulatory bodies under the AMRH initiative — meaning EDA-registered products can benefit from expedited review in participating African countries. This is a structural advantage Egyptian manufacturers have over non-African competitors.
Africa Registration Guide Request a Market Assessment
Supply Chain & Regulatory Consulting
Supply Chain Outsourcing & Pilot Batch Production
Coordination of sourcing, manufacturing partners, and pilot batch production runs. Moving a product from formulation to registerable batch without managing every vendor relationship directly.
Stability Studies
Design and follow-up of stability programmes in line with ICH and EDA guidelines (including ICH climate Zone IVb requirements), supporting shelf-life claims for EDA and Gulf registration dossiers.
Regulatory Consulting
Naming services, pricing negotiations with EDA's pricing committee, and Risk Management Plan (RMP) development — the regulatory groundwork that accompanies a submission.
Tell us which markets you need to be in.
Whether you are registering in Egypt for the first time, preparing your first Gulf eCTD submission, or planning African market entry — a 30-minute conversation maps the pathway and defines the scope.
Request a Registration Assessment