Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Nepal
DDA Nepal–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Nepal’s regulatory framework.
Our DMF services are designed to meet the requirements of the Department of Drug Administration (DDA), Ministry of Health and Population, Nepal and comply with:
Drug Act, 2035 (1978), Nepal
Drug Registration Regulation, Nepal
Nepal GMP Guidelines
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & 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 full regulatory compliance, strict confidentiality, and smooth approval processing in Nepal.
Our Core DMF Services – Nepal
🧪 DMF Preparation – Open & Closed Parts (Nepal-Compliant)
We prepare complete, structured, and DDA-aligned DMF dossiers following the CTD format accepted for Nepal submissions.
Applicant’s Part (Open Part)
Prepared for submission to DDA Nepal / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import License & Marketing Authorization
• CTD-structured documentation suitable for Nepal and global exports
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 materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone IVb climatic conditions applicable to Nepal
✅ Confidential data is disclosed strictly to DDA regulators and never to local applicants or distributors.
DMF Types Covered – Nepal
We support 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 – Nepal
Already have a DMF for Nepal?
We conduct Nepal-specific DMF review and risk assessment based on:
• DDA technical expectations & inspection practices
• Nepal GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DDA Submission & Nepal Regulatory Support
We provide hands-on support for DMF usage and filing in Nepal, including:
• DDA submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, DDA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Nepal
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DDA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DDA Nepal
Complete post-submission regulatory support for Nepal, including:
• DDA deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and DDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Nepal?
🧪 In-depth knowledge of DDA Nepal regulatory pathways
🧪 Expertise in Nepal GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DDA deficiency response experience
🧪 Seamless coordination with Nepalese MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Nepal
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Nepal
• Drug Act, 2035 (1978), Nepal
• Drug Registration Regulation, Nepal
• Nepal GMP Guidelines
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Nepal
Whether you are preparing a new DMF, updating an existing dossier, supporting a DDA Nepal submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Nepalese market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven