Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Fiji
FMRA-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 Fiji’s regulatory framework.
Our DMF services are designed to meet the expectations of the Fiji Medicines Regulatory Authority (FMRA) under the Ministry of Health & Medical Services (MoHMS), Fiji, and align with:
• Medicines and Related Substances Act – Fiji
• FMRA Guidelines
• WHO Good Manufacturing Practices (WHO-GMP)
• ICH Guidelines
• CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) approvals
• Import permit & registration 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 full regulatory compliance, strict confidentiality, and smooth approval processing in Fiji.
Our Core DMF Services – Fiji
🧪 DMF Preparation – Open & Closed Parts (Fiji-Compliant)
We prepare complete, structured, and FMRA-aligned DMF dossiers strictly following the CTD format accepted for Fijian regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to FMRA / Local Marketing Authorization Holders (MAH) / 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
– Manufacturing & WHO-GMP Certification
• CTD-structured documentation suitable for Fiji and Pacific Island markets
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process & process flow diagrams
• Critical process parameters (CPPs) & in-process controls (IPCs)
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2(R2))
• Control strategy & pharmaceutical quality system (PQS)
• Stability data as per Fiji climatic conditions (Zone IVb – hot & humid)
✅ Confidential data is disclosed only to FMRA regulators and is never shared with applicants or third parties.
DMF Types Covered – Fiji
We support CTD-based DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Fiji
Already have a DMF for Fiji?
We conduct a Fiji-specific DMF review and regulatory risk assessment based on:
• FMRA expectations and regulatory observations
• WHO-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely FMRA deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 FMRA Submission & Fiji Regulatory Support
We provide hands-on support for DMF usage and registration filing in Fiji, including:
• FMRA submissions and regulatory clarifications
• API registration support
• Import registration & permit dossiers
• Manufacturing & WHO-GMP documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Fiji
We manage your DMF throughout its complete regulatory lifecycle in Fiji, including:
• Initial DMF compilation
• Annual updates, renewals & variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• FMRA-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – FMRA
Complete post-submission regulatory support for Fiji, including:
• FMRA deficiency letters & technical queries
• Scientific justification & deficiency response drafting
• Revised Open & Closed Part submissions
• Alignment with MAH / local applicant responses
• Coordination between manufacturer, MAH, and FMRA
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Fiji?
🧪 In-depth knowledge of FMRA & Fiji regulatory pathways
🧪 Expertise in WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong FMRA deficiency response experience
🧪 Seamless coordination with Fijian MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Fiji
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Fiji
• Medicines and Related Substances Act – Fiji
• Fiji Medicines Regulatory Authority (FMRA) Guidelines
• WHO Good Manufacturing Practices (WHO-GMP)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO Technical Reports
Your Trusted Partner for DMF Excellence in Fiji
Whether you are preparing a new DMF, updating an existing dossier, supporting an FMRA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Fijian and Pacific Island pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven