Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Afghanistan
Afghanistan National Medicine Regulatory Authority–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 Afghanistan’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the expectations of:
Afghanistan National Medicines & Healthcare Regulatory Authority
(operating under the Ministry of Public Health – MoPH)
And comply with:
Afghanistan Medicines Law & Import Regulations
WHO-GMP Requirements
ICH Guidelines (Q-Series)
CTD-based dossier formats used for:
• API technical approval for Afghanistan
• Finished pharmaceutical product (FPP) registration
• Import registration dossiers
• Tender-based public supply approvals
• NGO & hospital supply 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 Afghanistan.
Our Core DMF Services – Afghanistan
🧪 DMF Preparation – Open & Closed Parts (Afghanistan-Compliant)
We prepare complete, structured, and Afghanistan-regulatory-aligned DMF dossiers following WHO-CTD formats accepted for medicine import and registration.
Applicant’s Part (Open Part)
Prepared for submission to Afghanistan Drug Regulatory Authority / Local Importers, 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
– Tender Submissions
– NGO & Institutional Supply
• CTD-structured documentation suitable for Afghanistan and donor-funded procurement
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 & validation (ICH Q2)
• Pharmaceutical Quality System (PQS)
• Stability data as per Afghanistan climatic conditions (Zone IVa – Hot & Dry)
✅ Confidential information is disclosed only to the Afghanistan regulatory authority — not to importers or commercial applicants.
DMF Types Covered – Afghanistan
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 – Afghanistan
Already have a DMF for Afghanistan?
We conduct Afghanistan-specific DMF review and regulatory risk assessment based on:
• Afghanistan registration office technical expectations
• WHO-GMP compliance status
• CTD structure & content gaps
• Manufacturing, validation & stability deficiencies
• Likely deficiency letter triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 Afghanistan Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Afghanistan, including:
• Product registration dossier support
• API technical document submission
• Import license documentation
• Tender & government supply regulatory support
• NGO procurement regulatory compliance
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, COPP, FSC, GMP & stability records
🧪 DMF Lifecycle Management & Maintenance – Afghanistan
We manage your DMF through its complete regulatory lifecycle, including:
• Initial DMF compilation
• Post-approval updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (accelerated & long-term)
• Specification & method revisions
• Authority-driven changes & re-registrations
🧪 Post-Submission Deficiency & Query Handling – Afghanistan
Complete post-submission regulatory support, including:
• Deficiency letters & clarification queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with local importers & authorities
• Coordination between manufacturer, applicant & regulator
🎯 Goal: Faster approvals, fewer objections, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Afghanistan?
🧪 Strong experience with Afghanistan import registration pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven deficiency response expertise
🧪 Seamless coordination with Afghan importers, NGOs & distributors
🧪 Backed by Zoesoe Exports Pvt Ltd’s international regulatory strength
Industries We Support – Afghanistan
• API manufacturers
• Finished formulation manufacturers
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• NGO, hospital & government suppliers
• Contract Manufacturing Organizations (CMOs)
Regulatory Standards Followed – Afghanistan
• Afghanistan Medicines Law & Import Regulations
• Afghanistan National 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 Afghanistan
Whether you are registering a product for Afghanistan, submitting an API technical file, supplying to government tenders, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Afghanistan pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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