Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Mauritius
Pharmacy Board–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 regulatory framework of Mauritius.
Our DMF services are designed to meet the expectations of the Pharmacy Board under the Ministry of Health & Wellness (MoHW), Mauritius, and align with:
• Dangerous Drugs Act & Pharmacy Act – Mauritius
• MoHW Guidelines for Registration of Medicinal Products
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
Used for:
• API registration
• Finished formulation product registration
• Import & marketing authorization 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 regulatory compliance, confidentiality, and smooth approval processing in Mauritius.
Our Core DMF Services – Mauritius
🧪 DMF Preparation – Open & Closed Parts (Mauritius-Compliant)
We prepare complete, structured, and Pharmacy Board–aligned DMF dossiers following CTD format accepted for Mauritian submissions.
Applicant’s Part (Open Part)
Prepared for submission to Pharmacy Board Mauritius / Local Marketing Authorization Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product registration
– Import permit & marketing authorization
• CTD-structured documentation suitable for Mauritius and select export markets
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 material, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality systems
• Stability data as per WHO Climatic Zone IVb (hot & humid – applicable to Mauritius)
✅ Confidential information is shared only with Mauritius regulators and never with applicants.
DMF Types Covered – Mauritius
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredient (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Mauritius
Already have a DMF for Mauritius?
We conduct Mauritius-specific DMF review and risk assessment based on:
• Pharmacy Board regulatory expectations and inspection observations
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Mauritius technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 Pharmacy Board Submission & Mauritius Regulatory Support
We provide hands-on support for DMF usage and filing in Mauritius, including:
• Pharmacy Board submissions and technical clarifications
• API registration support
• Import permit & marketing authorization dossiers
• Finished product registration documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and manufacturing documents
🧪 DMF Lifecycle Management & Maintenance – Mauritius
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and regulatory renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (accelerated & long-term)
• Specification and analytical method revisions
• Pharmacy Board–driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – Mauritius
Complete post-submission regulatory support, including:
• Pharmacy Board deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and MoHW authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Mauritius?
🧪 In-depth knowledge of Mauritius regulatory pathways
🧪 Strong expertise in WHO GMP and ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven experience in regulatory deficiency responses
🧪 Seamless coordination with Mauritian importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Mauritius
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Mauritius
• Pharmacy Act – Mauritius
• Dangerous Drugs Act – Mauritius
• Ministry of Health & Wellness Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
Your Trusted Partner for DMF Excellence in Mauritius
Whether you are preparing a new DMF, updating an existing dossier, supporting a Pharmacy Board submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Mauritian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven