Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – Qatar

Qatar MOPH–DRD–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 pharmaceutical regulatory framework of the State of Qatar.

Our DMF / ASMF services are designed to meet the expectations of:

• Ministry of Public Health (MOPH), State of Qatar

• Drug Registration Department (DRD)

• GCC Central & National Drug Registration Committees

And comply with:

• Qatar Drug Law & MOPH Regulations

• GCC Drug Registration Guidelines (GSDP)

• WHO-GMP & PIC/S-aligned GMP

• ICH Guidelines

• CTD / eCTD dossier formats used for:

• API technical approval in Qatar
• Finished pharmaceutical product (FPP) registration
• Import permit & marketing authorization
• Local agent & distributor submissions
• Government tenders & hospital supply registrations
• GCC regional & MENA export-oriented filings

We specialize in the preparation and maintenance of both:

1. Open Part (Applicant’s / MAH / Importer’s Part)

2. Closed Part (Restricted / Confidential Manufacturer’s Part)

Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with Qatar MOPH–DRD.

Our Core DMF / ASMF Services – Qatar

🧪 DMF / ASMF Preparation – Open & Closed Parts (Qatar-Compliant)

We prepare complete, structured, and MOPH-aligned DMF / ASMF dossiers following CTD/eCTD formats accepted for Qatar and GCC regulatory submissions.

Applicant’s Part (Open Part)

Prepared for submission to Qatar MOPH–DRD / Local MAHs & Importers, including:

• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– Qatar National Drug Registration
– Import Permit & Marketing Authorization
– Local Agent & Distributor Submissions
– Government & Private Hospital Tenders
• CTD-structured documentation suitable for Qatar & GCC markets

Restricted Part (Closed / Confidential Part)

Secure preparation and controlled handling of proprietary technical information, including:

• Detailed manufacturing process & validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Qatar climatic conditions (Zone IVb – Hot & Very Humid)

✅ Confidential data is disclosed only to MOPH–DRD assessors — not to importers or commercial partners.

DMF / ASMF Types Covered – Qatar

We support DMF / ASMF documentation for:

• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information

🧪 DMF / ASMF Review & Gap Assessment – Qatar

Already have a DMF / ASMF for Qatar?

We conduct Qatar-specific DMF / ASMF review and regulatory risk assessment based on:

• MOPH–DRD & GCC quality assessment expectations
• WHO-GMP & PIC/S compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely MOPH–DRD deficiency & technical query triggers

✔️ You receive a clear, actionable gap-assessment report before official submission.

🧪 Qatar MOPH–DRD Submission & Regulatory Support

We provide hands-on support for DMF / ASMF filing and regulatory usage in Qatar, including:

• Qatar drug registration submissions
• API technical file linkage
• Finished product registration dossiers
• Import permit & customs documentation
• Government tender & hospital supply regulatory support
• GCC-aligned regulatory strategy

Our team ensures:

• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, application, GMP & stability records

🧪 DMF / ASMF Lifecycle Management & Maintenance – Qatar

We manage your DMF / ASMF throughout its complete regulatory lifecycle, including:

• Initial DMF / ASMF compilation
• Post-approval variations & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (long-term & accelerated)
• Specification & analytical method revisions
• Authority-driven post-approval changes

🧪 Post-Submission Deficiency & Query Handling – Qatar

Complete post-submission regulatory support, including:

• MOPH–DRD deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Qatar MAHs & importers
• Coordination between manufacturer, applicant & MOPH

🎯 Goal: Faster approvals, fewer objections, and MOPH-ready DMF / ASMF documentation.

🧪 Why Choose DMF Direct for Qatar?

🧪 Strong expertise in Qatar MOPH–DRD & GCC regulatory pathways
🧪 Proven experience with WHO-GMP, PIC/S & ICH-aligned DMF / ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong post-submission deficiency response expertise
🧪 Seamless coordination with Qatar importers, MAHs & hospital suppliers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength

Industries We Support – Qatar

• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospital suppliers
• Tender-based suppliers
• Contract Manufacturing Organizations (CMOs)

Regulatory Standards Followed – Qatar

• Qatar Drug Law & MOPH Regulations
• MOPH–DRD Drug Registration Guidelines
• GCC Drug Unified Guidelines
• WHO-GMP & PIC/S
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• USP / BP / Ph. Eur. (as accepted)

Your Trusted Partner for DMF / ASMF Excellence in Qatar

Whether you are registering a product in Qatar, submitting an API technical file, supplying to hospitals or government tenders, or responding to MOPH–DRD regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Qatari pharmaceutical market.

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

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