Drug Master File (DMF) Preparation, Review & Regulatory Support Services – South Africa
SAHPRA-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 South Africa’s regulatory framework.
Our DMF services are designed to meet the expectations of:
South African Health Products Regulatory Authority (SAHPRA)
Department of Health, South Africa
And comply with:
Medicines and Related Substances Act, 1965
SAHPRA Registration & Quality Guidelines
South African GMP (aligned with WHO-GMP)
ICH Guidelines
CTD / eCTD-based dossier formats used for:
• API technical registration & linkage in South Africa
• Finished formulation (FPP) product registration
• Import & marketing authorization dossiers
• Local MAH & distributor submissions
• Export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with SAHPRA.
Our Core DMF Services – South Africa
🧪 DMF Preparation – Open & Closed Parts (South Africa–Compliant)
We prepare complete, structured, and SAHPRA-aligned DMF dossiers following CTD/eCTD formats accepted for South African submissions.
Applicant’s Part (Open Part)
Prepared for submission to SAHPRA / South African MAHs / Distributors, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– Medicine Registration Applications
– Import & Marketing Authorization
– Local MAH & Distribution Licensing
• CTD-structured documentation suitable for South Africa and SADC region exports
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing processes & process flow diagrams
• Critical process parameters & in-process controls
• Raw material, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per South Africa climatic conditions (Climatic Zone IVb – Hot & Humid)
✅ Confidential data is disclosed only to SAHPRA assessors — not to MAHs or commercial partners.
DMF Types Covered – South Africa
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (APIs), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – South Africa
Already have a DMF for South Africa?
We conduct South Africa-specific DMF review and regulatory risk assessment based on:
• SAHPRA quality assessment expectations
• WHO-GMP & SA GMP compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely SAHPRA deficiency & backlog-related query triggers
✔️ You receive a clear, actionable gap assessment report before SAHPRA submission or inspection.
🧪 SAHPRA Submission & South Africa Regulatory Support
We provide hands-on support for DMF filing and regulatory usage in South Africa, including:
• SAHPRA electronic & paper submissions
• API registration & technical linkage support
• Medicine product registration dossiers
• Import & marketing authorization support
• SADC export-aligned DMF documentation
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF, registration dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – South Africa
We manage your DMF through its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• SAHPRA-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – South Africa
Complete post-submission regulatory support, including:
• SAHPRA deficiency letters & assessment queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with local MAH & distributor responses
• Coordination between manufacturer, MAH & SAHPRA
🎯 Goal: Faster approvals, fewer queries, and SAHPRA-ready DMF documentation.
🧪 Why Choose DMF Direct for South Africa?
🧪 Deep expertise in SAHPRA regulatory pathways & backlog-management strategy
🧪 Strong experience with WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven SAHPRA deficiency & technical query response success
🧪 Seamless coordination with South African MAHs & distributors
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – South Africa
• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• Importers & local MAHs
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – South Africa
• Medicines and Related Substances Act, South Africa
• SAHPRA Quality & Registration Guidelines
• WHO-GMP & PIC/S-aligned GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• SADC & African regulatory alignment (where applicable)
Your Trusted Partner for DMF Excellence in South Africa
Whether you are preparing a new DMF, updating an existing SAHPRA technical file, supporting a medicine registration, appointing a South African MAH, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the South African market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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