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