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