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