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