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