Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Ghana
FDA Ghana–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 Ghana’s regulatory framework.
Our DMF services are designed to meet the expectations of the Food and Drugs Authority (FDA), Ghana and align with:
• Public Health Act, 2012 (Act 851)
• FDA Ghana Guidelines for Medicinal Product Registration
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
• West African Health Organization (WAHO) / ECOWAS harmonized requirements
Used for:
• API registration
• Finished formulation product registration
• Import permit 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 Ghana.
Our Core DMF Services – Ghana
🧪 DMF Preparation – Open & Closed Parts (Ghana-Compliant)
We prepare complete, structured, and FDA Ghana–aligned DMF dossiers following CTD format accepted for Ghana submissions.
Applicant’s Part (Open Part)
Prepared for submission to FDA Ghana / 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 applications
– Marketing authorization
• CTD-structured documentation suitable for Ghana and ECOWAS markets
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and 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 Ghana)
✅ Confidential information is shared only with FDA Ghana regulators and never with applicants.
DMF Types Covered – Ghana
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 – Ghana
Already have a DMF for Ghana?
We conduct Ghana-specific DMF review and risk assessment based on:
• FDA Ghana regulatory expectations and inspection observations
• WHO GMP compliance gaps
• CTD format and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely FDA Ghana technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 FDA Ghana Submission & Ghana Regulatory Support
We provide hands-on support for DMF usage and filing in Ghana, including:
• FDA Ghana submissions and technical clarifications
• API registration support
• Import permit 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 – Ghana
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
• FDA Ghana–driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – FDA Ghana
Complete post-submission regulatory support, including:
• FDA Ghana deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and FDA Ghana authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Ghana?
🧪 In-depth knowledge of FDA Ghana & 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 Ghanaian importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Ghana
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Ghana
• Public Health Act, 2012 (Act 851) – Ghana
• FDA Ghana 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 Ghana
Whether you are preparing a new DMF, updating an existing dossier, supporting an FDA Ghana submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Ghanaian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven