Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Egypt
EDA Egypt–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Egypt’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Egyptian Drug Authority (EDA) and comply with:
Egyptian Pharmaceutical Law & Executive Regulations
EDA Drug Registration & Variation Guidelines
Egypt GMP (aligned with WHO/EU GMP)
ICH Guidelines
CTD / eCTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization (MA) dossiers
• Export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing in Egypt.
Our Core DMF Services – Egypt
🧪 DMF Preparation – Open & Closed Parts (Egypt-Compliant)
We prepare complete, structured, and EDA-aligned DMF dossiers following the CTD / eCTD format mandatory for Egypt submissions.
Applicant’s Part (Open Part)
Prepared for submission to EDA Egypt / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import License & Marketing Authorization
• CTD/eCTD-structured documentation suitable for Egypt and global exports
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone III & IVb climatic conditions applicable to Egypt
✅ Confidential data is disclosed strictly to EDA regulators and never to local applicants or distributors.
DMF Types Covered – Egypt
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Egypt
Already have a DMF for Egypt?
We conduct Egypt-specific DMF review and risk assessment based on:
• EDA technical expectations & inspection practices
• Egypt GMP compliance gaps
• CTD/eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely EDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 EDA Submission & Egypt Regulatory Support
We provide hands-on support for DMF usage and filing in Egypt, including:
• EDA submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD/eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, EDA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Egypt
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and post-approval variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• EDA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – EDA Egypt
Complete post-submission regulatory support for Egypt, including:
• EDA deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and EDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Egypt?
🧪 In-depth knowledge of EDA Egypt regulatory pathways
🧪 Expertise in Egypt GMP, WHO/EU GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong EDA deficiency response experience
🧪 Seamless coordination with Egyptian MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Egypt
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Egypt
• Egyptian Pharmaceutical Law & Executive Regulations
• Egyptian Drug Authority (EDA) Guidelines
• Egypt GMP (WHO/EU aligned)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Egypt
Whether you are preparing a new DMF, updating an existing dossier, supporting an EDA Egypt submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Egyptian market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven