Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Saudi Arabia
SFDA-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 Saudi Arabia’s regulatory framework.
Our DMF services are designed to meet the requirements of the Saudi Food & Drug Authority (SFDA) and comply with:
Saudi Drug Law & SFDA Regulations
GMP Guidelines of SFDA
ICH Guidelines
CTD & eCTD-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 Saudi Arabia.
Our Core DMF Services – Saudi Arabia
🧪 DMF Preparation – Open & Closed Parts (Saudi Arabia–Compliant)
We prepare complete, structured, and SFDA-aligned DMF dossiers following the CTD/eCTD format mandatory for Saudi Arabia submissions.
Applicant’s Part (Open Part)
Prepared for submission to SFDA / 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/eCTD-structured documentation suitable for Saudi Arabia 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 Saudi Arabia
✅ Confidential data is disclosed strictly to SFDA regulators and never to local applicants or distributors.
DMF Types Covered – Saudi Arabia
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 – Saudi Arabia
Already have a DMF for Saudi Arabia?
We conduct Saudi Arabia–specific DMF review and risk assessment based on:
• SFDA technical expectations & inspection practices
• GMP compliance gaps
• CTD/eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely SFDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 SFDA Submission & Saudi Arabia Regulatory Support
We provide hands-on support for DMF usage and filing in Saudi Arabia, including:
• SFDA submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD/eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, SFDA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Saudi Arabia
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
• SFDA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – SFDA
Complete post-submission regulatory support for Saudi Arabia, including:
• SFDA 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 SFDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Saudi Arabia?
🧪 In-depth knowledge of SFDA regulatory pathways
🧪 Expertise in SFDA GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong SFDA deficiency response experience
🧪 Seamless coordination with Saudi MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Saudi Arabia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Saudi Arabia
• Saudi Drug Law & SFDA Regulations
• SFDA GMP Guidelines
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Saudi Arabia
Whether you are preparing a new DMF, updating an existing dossier, supporting an SFDA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Saudi Arabian market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven