Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Liberia
LMHRA–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 the pharmaceutical regulatory framework of the Republic of Liberia.
Our DMF services are designed to meet the expectations of:
Liberia Medicines & Health Products Regulatory Authority (LMHRA)
Ministry of Health, Republic of Liberia
National Drug Regulatory Authority – Liberia
And comply with:
Liberia Medicines & Health Products Act
LMHRA Drug Registration Regulations
WHO-GMP Requirements
ICH Guidelines (Q-Series)
CTD-based dossier formats used for:
• API technical approval in Liberia
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization
• Local agent & distributor submissions
• Government, hospital & NGO supply dossiers
• West African export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / Importer’s Part)
Closed Part (Restricted / Confidential Manufacturer’s Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with LMHRA.
Our Core DMF Services – Liberia
🧪 DMF Preparation – Open & Closed Parts (Liberia-Compliant)
We prepare complete, structured, and LMHRA-aligned DMF dossiers following CTD formats accepted for medicine registration and import in Liberia.
Applicant’s Part (Open Part)
Prepared for submission to LMHRA / Liberia Importers & Distributors, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– Product Registration Certificates
– Import Licenses
– Hospital, Government & NGO Supply
– Local Agent & Distributor Submissions
• CTD-structured documentation suitable for Liberia & West African markets
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & flow diagrams
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2)
• Pharmaceutical Quality System (PQS)
• Stability data as per Liberia climatic conditions (Zone IVa – Hot & Humid)
✅ Confidential information is disclosed only to LMHRA regulators — not to importers or commercial applicants.
DMF Types Covered – Liberia
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API)
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Liberia
Already have a DMF for Liberia?
We conduct Liberia-specific DMF review and regulatory risk assessment based on:
• LMHRA technical assessment expectations
• WHO-GMP compliance status
• CTD structure & content gaps
• Manufacturing, validation & stability deficiencies
• Likely LMHRA technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 Liberia Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Liberia, including:
• Product registration dossier support
• API technical document submission
• Import license documentation
• Hospital, tender & NGO supply regulatory support
• Coordination with local agents & distributors
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, COPP, FSC, GMP & stability records
🧪 DMF Lifecycle Management & Maintenance – Liberia
We manage your DMF through its complete regulatory lifecycle, including:
• Initial DMF compilation
• Post-approval updates & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (accelerated & long-term)
• Specification & analytical method revisions
• Authority-driven changes & re-registrations
🧪 Post-Submission Deficiency & Query Handling – Liberia
Complete post-submission regulatory support, including:
• LMHRA deficiency letters & clarification queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Liberia importers & authorities
• Coordination between manufacturer, applicant & LMHRA
🎯 Goal: Faster approvals, fewer objections, and LMHRA-ready DMF documentation.
🧪 Why Choose DMF Direct for Liberia?
🧪 Strong experience with Liberia import registration pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven deficiency response expertise
🧪 Seamless coordination with Liberia importers, hospitals & NGO partners
🧪 Backed by Zoesoe Exports Pvt Ltd’s international regulatory strength
Industries We Support – Liberia
• API manufacturers
• Finished formulation manufacturers
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospitals
• NGO & donor-funded suppliers
• Contract Manufacturing Organizations (CMOs)
Regulatory Standards Followed – Liberia
• Liberia Medicines & Health Products Act
• LMHRA Drug Registration Guidelines
• WHO-GMP
• ICH Q-Series Guidelines
• CTD-structured documentation
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF Excellence in Liberia
Whether you are registering a product for Liberia, submitting an API technical file, supplying to hospitals, NGOs or government tenders, or responding to LMHRA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Liberian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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