Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Syria

Syrian MOH–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 Syria’s regulatory framework.

Our DMF services are designed to meet the requirements of the Syrian Ministry of Health (MOH), Directorate of Pharmaceutical Affairs (DPA) and comply with:

• Syrian Pharmaceutical Law & MOH Regulations

• Syrian Drug Registration Directives

• GMP Guidelines accepted by Syria

• 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:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing in Syria.

Our Core DMF Services – Syria

🧪 DMF Preparation – Open & Closed Parts (Syria-Compliant)

We prepare complete, structured, and Syrian MOH–aligned DMF dossiers following the CTD format accepted for Syrian submissions.

Applicant’s Part (Open Part)

Prepared for submission to Syrian MOH / 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 Syria 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 Syria

✅ Confidential data is disclosed strictly to Syrian MOH regulators and never to local applicants or distributors.

DMF Types Covered – Syria

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 – Syria

Already have a DMF for Syria?

We conduct Syria-specific DMF review and risk assessment based on:

• Syrian MOH technical expectations & inspection practices
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Syrian MOH deficiency triggers

✔️ You receive a clear, actionable gap assessment report before submission or inspection.

🧪 Syrian MOH Submission & Regulatory Support

We provide hands-on support for DMF usage and filing in Syria, including:

• Syrian MOH 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, Syrian MOH dossiers, and manufacturing records

🧪 DMF Lifecycle Management & Maintenance – Syria

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
• Syrian MOH-driven amendments and updates

🧪 Post-Submission Deficiency & Query Handling – Syrian MOH

Complete post-submission regulatory support for Syria, including:

• Syrian MOH 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 Syrian MOH authority

🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.

🧪 Why Choose DMF Direct for Syria?

🧪 In-depth knowledge of Syrian MOH regulatory pathways
🧪 Expertise in Syria GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong Syrian MOH deficiency response experience
🧪 Seamless coordination with Syrian MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength

Industries We Support – Syria

• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)

Regulatory Standards Followed – Syria

• Syrian Pharmaceutical Law & MOH Decrees
• Syrian MOH Drug Registration Guidelines
• Syria GMP Regulations
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports

Your Trusted Partner for DMF Excellence in Syria

Whether you are preparing a new DMF, updating an existing dossier, supporting a Syrian MOH submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Syrian market.

✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven