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