Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Seychelles
SMRA–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 Republic of Seychelles.
Our DMF services are designed to meet the expectations of:
Seychelles Medicines Regulatory Authority (SMRA)
Ministry of Health, Republic of Seychelles
And comply with:
Seychelles Medicines Act & SMRA Regulations
WHO-GMP Requirements
ICH Guidelines (Q-Series)
CTD-based dossier formats used for:
• API technical approval in Seychelles
• Finished pharmaceutical product (FPP) registration
• Import permit & marketing authorization
• Local agent & distributor submissions
• Government, hospital & NGO supply dossiers
• Island nation 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 SMRA.
Our Core DMF Services – Seychelles
🧪 DMF Preparation – Open & Closed Parts (Seychelles-Compliant)
We prepare complete, structured, and SMRA-aligned DMF dossiers following CTD formats accepted for medicine registration and import in Seychelles.
Applicant’s Part (Open Part)
Prepared for submission to SMRA / Seychelles 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 Permits
– Hospital, Government & NGO Supply
– Local Agent & Distributor Submissions
• CTD-structured documentation suitable for Seychelles & Indian Ocean island 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 Seychelles climatic conditions (Zone IVb – Hot & Very Humid)
✅ Confidential information is disclosed only to SMRA regulators — not to importers or commercial applicants.
DMF Types Covered – Seychelles
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 – Seychelles
Already have a DMF for Seychelles?
We conduct Seychelles-specific DMF review and regulatory risk assessment based on:
• SMRA technical assessment expectations
• WHO-GMP compliance status
• CTD structure & content gaps
• Manufacturing, validation & stability deficiencies
• Likely SMRA technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 Seychelles Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Seychelles, including:
• Product registration dossier support
• API technical document submission
• Import permit documentation
• Hospital, tender & NGO supply 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 – Seychelles
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 – Seychelles
Complete post-submission regulatory support, including:
• SMRA deficiency letters & clarification queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Seychelles importers & authorities
• Coordination between manufacturer, applicant & SMRA
🎯 Goal: Faster approvals, fewer objections, and SMRA-ready DMF documentation.
🧪 Why Choose DMF Direct for Seychelles?
🧪 Strong experience with Seychelles import registration pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven deficiency response expertise
🧪 Seamless coordination with Seychelles importers, hospitals & government buyers
🧪 Backed by Zoesoe Exports Pvt Ltd’s international regulatory strength
Industries We Support – Seychelles
• 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 – Seychelles
• Seychelles Medicines Act & SMRA Regulations
• SMRA 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 Seychelles
Whether you are registering a product for Seychelles, submitting an API technical file, supplying to hospitals, NGOs or government tenders, or responding to SMRA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Seychelles pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
If you want, I can also prepare:
✅ Seychelles–Mauritius–Madagascar Indian Ocean regional DMF version
✅ SEO landing page for “DMF Services for Seychelles”
✅ Export-focused Seychelles DMF services page for Indian API & FDF manufacturers