Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Benin
ABRP–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 Benin.
Our DMF services are designed to meet the expectations of:
Agence Béninoise de Régulation Pharmaceutique (ABRP)
Ministry of Health, Republic of Benin
West African Health Organization (WAHO)
ECOWAS Regional Medicines Harmonization Program
And comply with:
Benin Medicines Law & ABRP Regulations
ECOWAS/WAHO Harmonized Technical Guidelines
WHO-GMP Requirements
ICH Guidelines (Q-Series)
CTD-based dossier formats used for:
• API technical approval in Benin
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization
• Local agent & distributor submissions
• Government tenders, hospitals & NGO supply dossiers
• ECOWAS regional export-oriented 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 ABRP.
Our Core DMF Services – Benin
🧪 DMF Preparation – Open & Closed Parts (Benin-Compliant)
We prepare complete, structured, and ABRP-aligned DMF dossiers following CTD formats accepted for medicine registration and import in Benin.
Applicant’s Part (Open Part)
Prepared for submission to ABRP / Benin 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 Benin & ECOWAS 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 Benin climatic conditions (Zone IVb – Hot & Very Humid)
✅ Confidential information is disclosed only to ABRP regulators — not to importers or commercial applicants.
DMF Types Covered – Benin
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 – Benin
Already have a DMF for Benin?
We conduct Benin-specific DMF review and regulatory risk assessment based on:
• ABRP technical assessment expectations
• WHO-GMP compliance status
• CTD structure & content gaps
• Manufacturing, validation & stability deficiencies
• Likely ABRP technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 Benin Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Benin, 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 – Benin
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 – Benin
Complete post-submission regulatory support, including:
• ABRP deficiency letters & clarification queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Benin importers & authorities
• Coordination between manufacturer, applicant & ABRP
🎯 Goal: Faster approvals, fewer objections, and ABRP-ready DMF documentation.
🧪 Why Choose DMF Direct for Benin?
🧪 Strong experience with Benin import registration pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven deficiency response expertise
🧪 Seamless coordination with Benin importers, hospitals & distributors
🧪 Backed by Zoesoe Exports Pvt Ltd’s international regulatory strength
Industries We Support – Benin
• 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 – Benin
• Benin Medicines Law & ABRP Regulations
• ECOWAS/WAHO Harmonized Guidelines
• WHO-GMP
• ICH Q-Series Guidelines
• CTD-structured documentation
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF Excellence in Benin
Whether you are registering a product for Benin, submitting an API technical file, supplying to hospitals, NGOs or government tenders, or responding to ABRP regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Benin pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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