Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – South Africa
SAHPRA–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for the pharmaceutical regulatory framework of the Republic of South Africa.
Our DMF / ASMF services are designed to meet the expectations of:
South African Health Products Regulatory Authority (SAHPRA)
National Department of Health, South Africa
And comply with:
Medicines and Related Substances Act, 1965 (Act 101 of 1965)
SAHPRA Registration & Quality Guidelines
PIC/S GMP (South Africa is PIC/S aligned)
ICH Guidelines
CTD / eCTD dossier formats used for:
• API technical approval in South Africa
• Finished pharmaceutical product (FPP) registration
• Import / export permits
• Local MAH & distributor submissions
• Government tenders & hospital supply registrations
• SADC regional export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / MAH / Importer’s Part)
Closed Part (Restricted / Confidential Manufacturer’s Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with SAHPRA.
Our Core DMF / ASMF Services – South Africa
🧪 DMF / ASMF Preparation – Open & Closed Parts (SAHPRA-Compliant)
We prepare complete, structured, and SAHPRA-aligned DMF / ASMF dossiers following CTD/eCTD formats accepted for South African regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to SAHPRA / South African MAHs & Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– South Africa New Product Registration
– Import / Export Permits
– Government & Private Hospital Tenders
– Local MAH & Distributor Submissions
• CTD-structured documentation suitable for South Africa & global markets
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per South Africa climatic conditions (Zone II & IVa as applicable)
✅ Confidential data is disclosed only to SAHPRA assessors — not to applicants or commercial partners.
DMF / ASMF Types Covered – South Africa
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – South Africa
Already have a DMF / ASMF for South Africa?
We conduct South Africa–specific DMF / ASMF review and regulatory risk assessment based on:
• SAHPRA quality assessment expectations
• PIC/S GMP compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely SAHPRA deficiency & technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 SAHPRA Submission & South Africa Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in South Africa, including:
• SAHPRA product registration submissions
• API technical file linkage
• Finished product registration dossiers
• Import / export permit documentation
• Government tender & hospital supply regulatory support
• SADC-aligned regulatory strategy
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, application, GMP & stability records
🧪 DMF / ASMF Lifecycle Management & Maintenance – South Africa
We manage your DMF / ASMF throughout its complete regulatory lifecycle, including:
• Initial DMF / ASMF compilation
• Post-approval variations & line extensions
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (long-term & accelerated)
• Specification & analytical method revisions
• Authority-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – South Africa
Complete post-submission regulatory support, including:
• SAHPRA deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with South African MAHs & applicants
• Coordination between manufacturer, applicant & SAHPRA
🎯 Goal: Faster approvals, fewer objections, and SAHPRA-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for South Africa?
🧪 Strong expertise in SAHPRA & SADC regulatory pathways
🧪 Proven experience with PIC/S GMP & ICH-aligned DMF / ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong post-submission deficiency response expertise
🧪 Seamless coordination with South African MAHs, importers & hospital suppliers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – South Africa
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospital suppliers
• Tender-based suppliers
• Contract Manufacturing Organizations (CMOs)
Regulatory Standards Followed – South Africa
• Medicines & Related Substances Act, 1965
• SAHPRA Registration & Quality Guidelines
• PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• South African Pharmacopoeia / USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF / ASMF Excellence in South Africa
Whether you are registering a product in South Africa, submitting an API technical file, supplying to hospitals or government tenders, or responding to SAHPRA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the South African pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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