Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Libya
LDCC-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 Libya’s regulatory framework.
Our DMF services are designed to meet the expectations of the Libyan Drug Control Center (LDCC) and align with:
• Libyan Pharmaceutical Law & Implementing Regulations
• LDCC Guidelines for Medicinal Product Registration
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
Used for:
• API registration
• Finished formulation product registration
• Import license 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 Libya.
Our Core DMF Services – Libya
🧪 DMF Preparation – Open & Closed Parts (Libya-Compliant)
We prepare complete, structured, and LDCC-aligned DMF dossiers following CTD format accepted for Libyan submissions.
Applicant’s Part (Open Part)
Prepared for submission to LDCC / 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 license applications
– Marketing authorization
• CTD-structured documentation suitable for Libya 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 IV (hot – applicable to Libya)
✅ Confidential information is shared only with LDCC regulators and never with applicants.
DMF Types Covered – Libya
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 – Libya
Already have a DMF for Libya?
We conduct Libya-specific DMF review and risk assessment based on:
• LDCC regulatory expectations and inspection observations
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely LDCC technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 LDCC Submission & Libya Regulatory Support
We provide hands-on support for DMF usage and filing in Libya, including:
• LDCC submissions and technical clarifications
• API registration support
• Import license 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 – Libya
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
• LDCC-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – LDCC Libya
Complete post-submission regulatory support, including:
• LDCC deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and LDCC authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Libya?
🧪 In-depth knowledge of LDCC & 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 Libyan importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Libya
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Libya
• Libyan Pharmaceutical Law & Executive Regulations
• LDCC Libya Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
Your Trusted Partner for DMF Excellence in Libya
Whether you are preparing a new DMF, updating an existing dossier, supporting an LDCC submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Libyan pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven