Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Malaysia
NPRA Malaysia–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 Malaysia’s regulatory framework.
Our DMF services are designed to meet the requirements of the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia and comply with:
Malaysian Drug Control Authority (DCA) Regulations
Sale of Drugs Act 1952 & Control of Drugs and Cosmetics Regulations (CDCR 1984)
PIC/S GMP Guidelines adopted by Malaysia
ICH Guidelines
ASEAN CTD (ACTD) / CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & product notification
• 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 Malaysia.
Our Core DMF Services – Malaysia
🧪 DMF Preparation – Open & Closed Parts (Malaysia-Compliant)
We prepare complete, structured, and NPRA-aligned DMF dossiers following the ACTD / CTD format accepted for Malaysia submissions.
Applicant’s Part (Open Part)
Prepared for submission to NPRA / Local Product Registration Holders (PRH) / 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 (MAL Number)
– Import License & Product Notification
• ACTD/CTD-structured documentation suitable for Malaysia 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 Malaysia
✅ Confidential data is disclosed strictly to NPRA regulators and never to local applicants or distributors.
DMF Types Covered – Malaysia
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 – Malaysia
Already have a DMF for Malaysia?
We conduct Malaysia-specific DMF review and risk assessment based on:
• NPRA technical expectations & inspection practices
• PIC/S GMP compliance gaps
• ACTD/CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely NPRA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 NPRA Submission & Malaysia Regulatory Support
We provide hands-on support for DMF usage and filing in Malaysia, including:
• NPRA submissions and clarifications
• API registration support
• Finished product registration (MAL No.)
• Import license & product notification dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct ACTD/CTD formatting
• Accurate cross-referencing
• Consistency across DMF, NPRA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Malaysia
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
• NPRA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – NPRA
Complete post-submission regulatory support for Malaysia, including:
• NPRA deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with Product Registration Holder (PRH) responses
• Coordination between manufacturer, PRH, and NPRA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Malaysia?
🧪 In-depth knowledge of NPRA & DCA regulatory pathways
🧪 Expertise in PIC/S GMP, ASEAN & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong NPRA deficiency response experience
🧪 Seamless coordination with Malaysian PRHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Malaysia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Product Registration Holders (PRHs), importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Malaysia
• Sale of Drugs Act 1952 & CDCR 1984
• NPRA & DCA Guidelines
• PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• ACTD / CTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Malaysia
Whether you are preparing a new DMF, updating an existing dossier, supporting an NPRA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Malaysian market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven