Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Ethiopia
EFDA–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 Ethiopia’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Ethiopian Food and Drug Authority (EFDA) and comply with:
Ethiopian Food and Drug Administration Proclamation
EFDA Medicines Registration Directives
GMP Guidelines accepted in Ethiopia (WHO GMP aligned)
ICH Guidelines
CTD / eCTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import permit & 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 Ethiopia.
Our Core DMF Services – Ethiopia
🧪 DMF Preparation – Open & Closed Parts (Ethiopia-Compliant)
We prepare complete, structured, and EFDA-aligned DMF dossiers following the CTD / eCTD format accepted for Ethiopia submissions.
Applicant’s Part (Open Part)
Prepared for submission to EFDA Ethiopia / 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 Permit & Marketing Authorization
• CTD-structured documentation suitable for Ethiopia 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 IVb climatic conditions applicable to Ethiopia
✅ Confidential data is disclosed strictly to EFDA regulators and never to local applicants or distributors.
DMF Types Covered – Ethiopia
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 – Ethiopia
Already have a DMF for Ethiopia?
We conduct Ethiopia-specific DMF review and risk assessment based on:
• EFDA technical expectations & inspection practices
• WHO-GMP compliance gaps
• CTD/eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely EFDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 EFDA Submission & Ethiopia Regulatory Support
We provide hands-on support for DMF usage and filing in Ethiopia, including:
• EFDA submissions and clarifications
• API registration support
• Finished product registration support
• Import permit & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD/eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, EFDA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Ethiopia
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
• EFDA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – EFDA Ethiopia
Complete post-submission regulatory support for Ethiopia, including:
• EFDA 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 EFDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Ethiopia?
🧪 In-depth knowledge of EFDA regulatory pathways
🧪 Expertise in Ethiopia GMP, WHO GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong EFDA deficiency response experience
🧪 Seamless coordination with Ethiopian MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Ethiopia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Ethiopia
• Ethiopian Food & Drug Proclamation
• EFDA Guidelines & Directives
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO Technical Reports
Your Trusted Partner for DMF Excellence in Ethiopia
Whether you are preparing a new DMF, updating an existing dossier, supporting an EFDA Ethiopia submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Ethiopian market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven