Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Tunisia
DPM Tunisia–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Tunisia’s regulatory framework.
Our DMF services are designed to meet the expectations of the Direction de la Pharmacie et du Médicament (DPM), Ministry of Health, Tunisia, and align with:
• Code du Médicament – Tunisia
• DPM Tunisia Guidelines for Medicinal Product Registration
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
• Arab & North African regulatory harmonization practices
Used for:
• API registration
• Finished formulation product registration
• Import authorization 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 regulatory compliance, confidentiality, and smooth approval processing in Tunisia.
Our Core DMF Services – Tunisia
🧪 DMF Preparation – Open & Closed Parts (Tunisia-Compliant)
We prepare complete, structured, and DPM-aligned DMF dossiers following CTD format accepted for Tunisian submissions.
Applicant’s Part (Open Part)
Prepared for submission to DPM Tunisia / Local Marketing Authorization Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product registration
– Import authorization
– Marketing authorization
• CTD-structured documentation suitable for Tunisia and North African markets
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 material, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality systems
• Stability data as per WHO Climatic Zone IVa–IVb (hot – applicable to Tunisia)
✅ Confidential information is shared only with DPM regulators and never with applicants.
DMF Types Covered – Tunisia
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredient (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Tunisia
Already have a DMF for Tunisia?
We conduct Tunisia-specific DMF review and risk assessment based on:
• DPM regulatory expectations and inspection observations
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DPM technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 DPM Submission & Tunisia Regulatory Support
We provide hands-on support for DMF usage and filing in Tunisia, including:
• DPM submissions and technical clarifications
• API registration support
• Import authorization dossier preparation
• Finished product registration documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and manufacturing documents
🧪 DMF Lifecycle Management & Maintenance – Tunisia
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and regulatory renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (accelerated & long-term)
• Specification and analytical method revisions
• DPM-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DPM Tunisia
Complete post-submission regulatory support, including:
• DPM deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and DPM authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Tunisia?
🧪 In-depth knowledge of DPM & North African regulatory pathways
🧪 Strong expertise in WHO GMP and ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven experience in regulatory deficiency responses
🧪 Seamless coordination with Tunisian importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Tunisia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Tunisia
• Code du Médicament – Tunisia
• DPM Tunisia Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
Your Trusted Partner for DMF Excellence in Tunisia
Whether you are preparing a new DMF, updating an existing dossier, supporting a DPM submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Tunisian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven