Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – United Arab Emirates (UAE)
MOHAP, DHA & DoH–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for the United Arab Emirates’ federal and emirate-level regulatory framework.
Our DMF/ASMF services are designed to meet the expectations of:
Ministry of Health & Prevention (MOHAP), UAE
Dubai Health Authority (DHA)
Department of Health – Abu Dhabi (DoH)
And comply with:
UAE Federal Drug & Medical Products Law
MOHAP Drug Registration Guidelines
UAE GMP (PIC/S & WHO-GMP aligned)
GCC Guidelines (GSDP)
ICH Guidelines
CTD / eCTD dossier formats used for:
• API technical registration & linkage in UAE
• Finished formulation (FPP) product registration
• Import permit & marketing authorization dossiers
• Local MAH & Authorized Distributor submissions
• GCC & MENA export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / MAH Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with MOHAP, DHA & DoH.
Our Core DMF / ASMF Services – United Arab Emirates
🧪 DMF / ASMF Preparation – Open & Closed Parts (UAE-Compliant)
We prepare complete, structured, and MOHAP-aligned ASMF dossiers following CTD/eCTD formats accepted for UAE and GCC regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to MOHAP / DHA / DoH / UAE Marketing Authorization Holders (MAHs), including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– UAE National Drug Registration
– Import Permit & Marketing Authorization
– Local MAH, Distributor & Agent Submissions
• CTD-structured documentation suitable for UAE and GCC-wide regulatory filings
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & process validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2 + USP / BP / Ph. Eur. as accepted by MOHAP)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per UAE climatic conditions (Zone IVb – Hot & Very Humid)
✅ Confidential data is disclosed only to UAE regulatory assessors — not to MAHs or commercial partners.
DMF / ASMF Types Covered – United Arab Emirates
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – United Arab Emirates
Already have a DMF / ASMF for the UAE?
We conduct UAE-specific DMF / ASMF review and regulatory risk assessment based on:
• MOHAP, DHA & DoH quality assessment expectations
• UAE GMP, WHO-GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely UAE deficiency & technical query triggers
✔️ You receive a clear, actionable gap assessment report before UAE submission or inspection.
🧪 MOHAP / DHA / DoH Submission & UAE Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in the UAE, including:
• MOHAP eCTD submissions
• API technical file linkage
• Finished product registration dossiers
• Import permit & customs clearance documentation
• Local MAH & distributor regulatory coordination
• GCC export-aligned DMF documentation
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF/ASMF, marketing authorization dossiers, and manufacturing records
🧪 DMF / ASMF Lifecycle Management & Maintenance – United Arab Emirates
We manage your DMF / ASMF through its complete regulatory lifecycle, including:
• Initial ASMF compilation
• Annual updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• MOHAP-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – United Arab Emirates
Complete post-submission regulatory support, including:
• MOHAP, DHA & DoH deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with UAE MAHs, importers & distributors
• Coordination between manufacturer, MAH & UAE authorities
🎯 Goal: Faster approvals, fewer queries, and MOHAP-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for the United Arab Emirates?
🧪 Deep expertise in MOHAP, DHA & DoH regulatory pathways
🧪 Strong experience with UAE GMP, WHO-GMP, PIC/S & ICH-aligned ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven UAE deficiency & technical query response success
🧪 Seamless coordination with UAE MAHs, importers & licensed distributors
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – United Arab Emirates
• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• UAE importers & local MAHs
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – United Arab Emirates
• UAE Federal Drug Law & MOHAP Regulations
• MOHAP Drug Registration Guidelines
• UAE GMP & WHO-GMP
• PIC/S & ICH Q-Series / M-Series Guidelines
• CTD / eCTD-ready documentation
• USP / BP / Ph. Eur. (as accepted by MOHAP)
• GCC Standardization Guidelines
Your Trusted Partner for DMF / ASMF Excellence in the United Arab Emirates
Whether you are preparing a new ASMF for the UAE, updating an existing MOHAP technical file, supporting a national product registration, appointing a UAE MAH & distributor, or responding to UAE regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the UAE and broader GCC market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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