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