Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Maldives

MFDA–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 Maldives.

Our DMF services are designed to meet the expectations of:

• Maldives Food and Drug Authority (MFDA)

• Ministry of Health, Maldives

And comply with:

• Maldives Medicines Act & MFDA Regulations

• MFDA Drug Registration Guidelines

• WHO-GMP Requirements

• ICH Guidelines (Q-Series)

• CTD-based dossier formats used for:

• API technical approval in the Maldives
• Finished pharmaceutical product (FPP) registration
• Import license & product registration
• Local agent & distributor submissions
• Hospital, government & private supply dossiers
• Export-oriented regulatory filings to island markets

We specialize in the preparation and maintenance of both:

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

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

Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with MFDA.

Our Core DMF Services – Maldives

🧪 DMF Preparation – Open & Closed Parts (Maldives-Compliant)

We prepare complete, structured, and MFDA-aligned DMF dossiers following CTD formats accepted for medicine import and registration in the Maldives.

Applicant’s Part (Open Part)

Prepared for submission to MFDA / Maldives Importers & Distributors, 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 Supply
– Local Agent & Distributor Submissions
• CTD-structured documentation suitable for the Maldives and small 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 Maldives climatic conditions (Zone IVb – Hot & Very Humid)

✅ Confidential information is disclosed only to MFDA regulators — not to importers or commercial applicants.

DMF Types Covered – Maldives

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 – Maldives

Already have a DMF for the Maldives?

We conduct Maldives-specific DMF review and regulatory risk assessment based on:

• MFDA technical assessment expectations
• WHO-GMP compliance status
• CTD structure & content gaps
• Manufacturing, validation & stability deficiencies
• Likely MFDA technical query triggers

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

🧪 Maldives Submission & Regulatory Support

We provide hands-on support for DMF usage and filing in the Maldives, including:

• Product registration dossier support
• API technical document submission
• Import license documentation
• Hospital & government 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 – Maldives

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 – Maldives

Complete post-submission regulatory support, including:

• MFDA deficiency letters & clarification queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Maldives importers & authorities
• Coordination between manufacturer, applicant & MFDA

🎯 Goal: Faster approvals, fewer objections, and MFDA-ready DMF documentation.

🧪 Why Choose DMF Direct for the Maldives?

🧪 Strong experience with Maldives import registration pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven deficiency response expertise
🧪 Seamless coordination with Maldives importers, hospitals & distributors
🧪 Backed by Zoesoe Exports Pvt Ltd’s international regulatory strength

Industries We Support – Maldives

• API manufacturers
• Finished formulation manufacturers
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Government & private hospitals
• Contract Manufacturing Organizations (CMOs)

Regulatory Standards Followed – Maldives

• Maldives Medicines Act & MFDA Regulations
• MFDA 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 the Maldives

Whether you are registering a product for the Maldives, submitting an API technical file, supplying to hospitals or government tenders, or responding to MFDA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Maldives pharmaceutical market.

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

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