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