Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Hong Kong
Hong Kong Department of Health–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 Hong Kong’s regulatory framework.
Our DMF services are designed to meet the requirements of the Hong Kong Department of Health (DH) and the Pharmacy and Poisons Board (PPB) and comply with:
Pharmacy and Poisons Ordinance (Cap. 138)
Drug Registration Guidance of Hong Kong
PIC/S GMP Guidelines adopted by Hong Kong
ICH Guidelines
CTD / eCTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & wholesaler support 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 Hong Kong.
Our Core DMF Services – Hong Kong
🧪 DMF Preparation – Open & Closed Parts (Hong Kong–Compliant)
We prepare complete, structured, and DH-aligned DMF dossiers following the CTD / eCTD format mandatory for Hong Kong submissions.
Applicant’s Part (Open Part)
Prepared for submission to Hong Kong DH / Local Applicants / MA Holders, 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 (PPB submission)
– Import License & Wholesale Registration
• CTD/eCTD-structured documentation suitable for Hong Kong 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 Hong Kong regulators and never to local applicants or distributors.
DMF Types Covered – Hong Kong
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 – Hong Kong
Already have a DMF for Hong Kong?
We conduct Hong Kong–specific DMF review and risk assessment based on:
• DH & PPB technical expectations
• PIC/S GMP compliance gaps
• CTD/eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely PPB deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 Hong Kong Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Hong Kong, including:
• Hong Kong DH & PPB submissions and clarifications
• API registration support
• Finished product registration support
• Import license & wholesaler documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD/eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, MA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Hong Kong
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and change notifications
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DH/PPB-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – Hong Kong DH
Complete post-submission regulatory support for Hong Kong, including:
• DH & PPB 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 Hong Kong authorities
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Hong Kong?
🧪 In-depth knowledge of Hong Kong DH & PPB regulatory pathways
🧪 Expertise in PIC/S GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong Hong Kong deficiency response experience
🧪 Seamless coordination with MA holders, importers & wholesalers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Hong Kong
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Hong Kong
• Pharmacy and Poisons Ordinance & Regulations (Cap. 138)
• Hong Kong DH & PPB Guidelines
• PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Hong Kong
Whether you are preparing a new DMF, updating an existing dossier, supporting a Hong Kong DH/PPB submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Hong Kong market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven