Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Singapore
HSA Singapore–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 Singapore’s highly regulated pharmaceutical market.
Our DMF services are designed to meet the requirements of the Health Sciences Authority (HSA), Singapore and comply with:
Medicines Act & Health Products Act (Singapore)
HSA Therapeutic Products Branch (TPB) Guidelines
PIC/S GMP Guidelines adopted by Singapore
ICH Guidelines
CTD & eCTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & product marketing authorization (MA)
• 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 Singapore.
Our Core DMF Services – Singapore
🧪 DMF Preparation – Open & Closed Parts (Singapore-Compliant)
We prepare complete, structured, and HSA-aligned DMF dossiers following the CTD / eCTD format mandatory for Singapore submissions.
Applicant’s Part (Open Part)
Prepared for submission to HSA Singapore / 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 (MA Application)
– Import License & Wholesaler Authorization
• CTD/eCTD-structured documentation suitable for Singapore 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 ICH climatic Zone IVb (where applicable)
✅ Confidential data is disclosed strictly to HSA regulators and never to local applicants or distributors.
DMF Types Covered – Singapore
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 – Singapore
Already have a DMF for Singapore?
We conduct Singapore-specific DMF review and risk assessment based on:
• HSA technical expectations & inspection practices
• PIC/S GMP compliance gaps
• CTD/eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely HSA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 HSA Submission & Singapore Regulatory Support
We provide hands-on support for DMF usage and filing in Singapore, including:
• HSA submissions and clarifications
• API registration support
• Finished product marketing authorization (MA)
• Import license & wholesaler documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD/eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, HSA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Singapore
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and post-approval variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• HSA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – HSA Singapore
Complete post-submission regulatory support for Singapore, including:
• HSA 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 HSA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Singapore?
🧪 In-depth knowledge of HSA Singapore regulatory pathways
🧪 Expertise in PIC/S GMP, Singapore & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong HSA deficiency response experience
🧪 Seamless coordination with Singapore MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Singapore
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & wholesalers
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Singapore
• Medicines Act & Health Products Act (Singapore)
• HSA Guidelines & Regulatory Circulars
• PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Singapore
Whether you are preparing a new DMF, updating an existing dossier, supporting a Singapore HSA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Singapore market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven