Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Philippines
Philippines 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 the Philippines’ regulatory framework.
Our DMF services are designed to meet the requirements of the Food and Drug Administration (FDA), Department of Health, Philippines and comply with:
Republic Act No. 9711 (FDA Act of 2009)
Republic Act No. 3720 (Food, Drug & Cosmetic Act, as amended)
Philippines FDA Regulations & GMP Guidelines
ASEAN GMP & ASEAN CTD (ACTD)
ICH Guidelines
ACTD / CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & product registration 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 the Philippines.
Our Core DMF Services – Philippines
🧪 DMF Preparation – Open & Closed Parts (Philippines-Compliant)
We prepare complete, structured, and Philippines FDA–aligned DMF dossiers following the ACTD / CTD format accepted for Philippine submissions.
Applicant’s Part (Open Part)
Prepared for submission to Philippines 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 & Certificate of Product Registration (CPR)
• ACTD/CTD-structured documentation suitable for the Philippines 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 the Philippines
✅ Confidential data is disclosed strictly to Philippines FDA regulators and never to local applicants or distributors.
DMF Types Covered – Philippines
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 – Philippines
Already have a DMF for the Philippines?
We conduct Philippines-specific DMF review and risk assessment based on:
• Philippines FDA technical expectations & inspection practices
• ASEAN GMP compliance gaps
• ACTD/CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Philippines FDA deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 Philippines FDA Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in the Philippines, including:
• Philippines FDA submissions and clarifications
• API registration support
• Finished product CPR registration support
• Import license & product registration dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct ACTD/CTD formatting
• Accurate cross-referencing
• Consistency across DMF, Philippines FDA dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Philippines
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
• Philippines FDA–driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – Philippines FDA
Complete post-submission regulatory support for the Philippines, including:
• Philippines 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 Philippines FDA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for the Philippines?
🧪 In-depth knowledge of Philippines FDA regulatory pathways
🧪 Expertise in ASEAN GMP, Philippines & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong Philippines FDA deficiency response experience
🧪 Seamless coordination with Philippine MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Philippines
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Philippines
• Republic Act 9711 & RA 3720
• Philippines FDA Guidelines & Circulars
• ASEAN GMP
• ICH Q-Series & M-Series Guidelines
• ACTD / CTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in the Philippines
Whether you are preparing a new DMF, updating an existing dossier, supporting a Philippines FDA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Philippine market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven