Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Morocco
Morocco DMP–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for the pharmaceutical regulatory framework of the Kingdom of Morocco.
Our DMF services are designed to meet the expectations of:
Ministry of Health & Social Protection, Morocco
Directorate of Medicines & Pharmacy (DMP)
Moroccan Drug Regulatory Authority
And comply with:
Morocco Medicines & Pharmacy Law (Law 17-04)
DMP Drug Registration Regulations
WHO-GMP Requirements
ICH Guidelines (Q-Series)
CTD-based dossier formats used for:
• API technical approval in Morocco
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization
• Local agent & distributor submissions
• Government, hospital & NGO supply dossiers
• North & West Africa export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / Importer’s / MAH Part)
Closed Part (Restricted / Confidential Manufacturer’s Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with Morocco DMP.
Our Core DMF Services – Morocco
🧪 DMF Preparation – Open & Closed Parts (Morocco-Compliant)
We prepare complete, structured, and DMP-aligned DMF dossiers following CTD formats accepted for medicine registration and import in Morocco.
Applicant’s Part (Open Part)
Prepared for submission to Morocco DMP / Importers & Marketing Authorization Holders (MAHs), including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– Product Registration Certificates
– Import Licenses
– Hospital, Government & NGO Supply
– Local Agent & Distributor Submissions
• CTD-structured documentation suitable for Morocco & Francophone Africa markets
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & flow diagrams
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2)
• Pharmaceutical Quality System (PQS)
• Stability data as per Morocco climatic conditions (Zone IVb – Hot & Humid)
✅ Confidential information is disclosed only to Morocco DMP regulators — not to importers or commercial applicants.
DMF Types Covered – Morocco
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API)
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Morocco
Already have a DMF for Morocco?
We conduct Morocco-specific DMF review and regulatory risk assessment based on:
• DMP technical assessment expectations
• WHO-GMP compliance status
• CTD structure & content gaps
• Manufacturing, validation & stability deficiencies
• Likely Morocco DMP technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 Morocco Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Morocco, including:
• Product registration dossier support
• API technical document submission
• Import license documentation
• Hospital & government tender regulatory support
• Coordination with local agents & distributors
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, COPP, FSC, GMP & stability records
🧪 DMF Lifecycle Management & Maintenance – Morocco
We manage your DMF through its complete regulatory lifecycle, including:
• Initial DMF compilation
• Post-approval updates & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (accelerated & long-term)
• Specification & analytical method revisions
• Authority-driven changes & re-registrations
🧪 Post-Submission Deficiency & Query Handling – Morocco
Complete post-submission regulatory support, including:
• Morocco DMP deficiency letters & clarification queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Morocco importers & authorities
• Coordination between manufacturer, applicant & DMP
🎯 Goal: Faster approvals, fewer objections, and DMP-ready DMF documentation.
🧪 Why Choose DMF Direct for Morocco?
🧪 Strong experience with Morocco import registration pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven deficiency response expertise
🧪 Seamless coordination with Morocco importers, hospitals & government buyers
🧪 Backed by Zoesoe Exports Pvt Ltd’s international regulatory strength
Industries We Support – Morocco
• API manufacturers
• Finished formulation manufacturers
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospitals
• NGO & donor-funded suppliers
• Contract Manufacturing Organizations (CMOs)
Regulatory Standards Followed – Morocco
• Morocco Medicines & Pharmacy Law (Law 17-04)
• Morocco DMP Drug Registration Guidelines
• WHO-GMP
• ICH Q-Series Guidelines
• CTD-structured documentation
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF Excellence in Morocco
Whether you are registering a product for Morocco, submitting an API technical file, supplying to hospitals, NGOs or government tenders, or responding to DMP regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Moroccan pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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