SBDMA Yemen–Compliant DMF Documentation & Regulatory Support
SBDMA Yemen–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Yemen’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Supreme Board of Drugs and Medical Appliances (SBDMA), Ministry of Public Health and Population, Yemen and comply with:
Yemeni Pharmacy Law & Drug Regulations
SBDMA Drug Registration Guidelines
GMP Guidelines accepted by Yemen
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization 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 full regulatory compliance, strict confidentiality, and smooth approval processing in Yemen.
Our Core DMF Services – Yemen
🧪 DMF Preparation – Open & Closed Parts (Yemen-Compliant)
We prepare complete, structured, and SBDMA-aligned DMF dossiers following the CTD format accepted for Yemen submissions.
Applicant’s Part (Open Part)
Prepared for submission to SBDMA Yemen / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import License & Marketing Authorization
• CTD-structured documentation suitable for Yemen and global exports
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 materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone IVb climatic conditions applicable to Yemen
✅ Confidential data is disclosed strictly to SBDMA regulators and never to local applicants or distributors.
DMF Types Covered – Yemen
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Yemen
Already have a DMF for Yemen?
We conduct Yemen-specific DMF review and risk assessment based on:
• SBDMA technical expectations & inspection practices
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely SBDMA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 SBDMA Submission & Yemen Regulatory Support
We provide hands-on support for DMF usage and filing in Yemen, including:
• SBDMA submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, SBDMA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Yemen
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• SBDMA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – SBDMA Yemen
Complete post-submission regulatory support for Yemen, including:
• SBDMA deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and SBDMA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Yemen?
🧪 In-depth knowledge of SBDMA Yemen regulatory pathways
🧪 Expertise in Yemen GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong SBDMA deficiency response experience
🧪 Seamless coordination with Yemeni MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Yemen
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Yemen
• Yemeni Pharmacy Law & Drug Regulations
• SBDMA Yemen Guidelines
• GMP Regulations accepted in Yemen
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Yemen
Whether you are preparing a new DMF, updating an existing dossier, supporting a Yemen SBDMA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Yemeni market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven