Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Thailand
Thai FDA–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 Thailand’s regulatory framework.
Our DMF services are designed to meet the requirements of the Thai Food and Drug Administration (Thai FDA), Ministry of Public Health (MOPH), Thailand and comply with:
Drug Act B.E. 2510 (1967), Thailand
Thai FDA Drug Registration Regulations
ASEAN GMP & PIC/S GMP
ICH Guidelines
ASEAN CTD (ACTD) / 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 Thailand.
Our Core DMF Services – Thailand
🧪 DMF Preparation – Open & Closed Parts (Thailand-Compliant)
We prepare complete, structured, and Thai FDA–aligned DMF dossiers following the ACTD / CTD format accepted for Thailand submissions.
Applicant’s Part (Open Part)
Prepared for submission to Thai FDA / 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
• ACTD/CTD-structured documentation suitable for Thailand 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 Thailand
✅ Confidential data is disclosed strictly to Thai FDA regulators and never to local applicants or distributors.
DMF Types Covered – Thailand
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 – Thailand
Already have a DMF for Thailand?
We conduct Thailand-specific DMF review and risk assessment based on:
• Thai FDA technical expectations & inspection practices
• ASEAN/PIC/S GMP compliance gaps
• ACTD/CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Thai FDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 Thai FDA Submission & Thailand Regulatory Support
We provide hands-on support for DMF usage and filing in Thailand, including:
• Thai FDA submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct ACTD/CTD formatting
• Accurate cross-referencing
• Consistency across DMF, Thai FDA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Thailand
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
• Thai FDA–driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – Thai FDA
Complete post-submission regulatory support for Thailand, including:
• Thai FDA 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 Thai FDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Thailand?
🧪 In-depth knowledge of Thai FDA regulatory pathways
🧪 Expertise in ASEAN GMP, PIC/S & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong Thai FDA deficiency response experience
🧪 Seamless coordination with Thai MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Thailand
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Thailand
• Drug Act B.E. 2510 (1967), Thailand
• Thai FDA Guidelines & MOPH Notifications
• ASEAN GMP & PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• ACTD / CTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Thailand
Whether you are preparing a new DMF, updating an existing dossier, supporting a Thai FDA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Thai market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven