Drug Master File (DMF) / ASMF Preparation, Review & Regulatory Support Services – Taiwan
TFDA–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for Taiwan’s pharmaceutical regulatory framework.
Our DMF / ASMF services are designed to meet the expectations of:
Taiwan Food and Drug Administration (TFDA)
Ministry of Health & Welfare (MOHW), Taiwan
And comply with:
Pharmaceutical Affairs Act, Taiwan
TFDA Drug Registration Regulations
PIC/S GMP (Taiwan is a PIC/S Member)
ICH Guidelines (Taiwan follows ICH principles)
CTD / eCTD dossier formats used for:
• API technical registration in Taiwan
• Finished pharmaceutical product (FPP) registration
• Import permit & Marketing Authorization (MA)
• Local agent & distributor submissions
• Post-approval variations & renewals
• Export-oriented global regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s / MAH / Importer’s Part)
Closed Part (Restricted / Confidential Manufacturer’s Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with TFDA.
Our Core DMF / ASMF Services – Taiwan
🧪 DMF / ASMF Preparation – Open & Closed Parts (Taiwan-Compliant)
We prepare complete, structured, and TFDA-aligned DMF / ASMF dossiers following CTD/eCTD formats accepted for Taiwan regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to TFDA / Taiwan MAHs & Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing & quality information
• Cross-reference-ready documentation for:
– Taiwan National Drug Registration
– Import Permit & Marketing Authorization
– Local Agent & Distributor Submissions
– Post-approval change applications
• CTD-structured documentation suitable for Taiwan & global markets
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2 + Taiwan Pharmacopoeia)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per Taiwan climatic conditions (Zone IVa – Hot & Humid)
✅ Confidential data is disclosed only to TFDA reviewers — not to importers or commercial partners.
DMF / ASMF Types Covered – Taiwan
We support DMF / ASMF documentation for:
• API / Drug Substance (ASMF)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – Taiwan
Already have a DMF / ASMF for Taiwan?
We conduct Taiwan-specific DMF / ASMF review and regulatory risk assessment based on:
• TFDA technical assessment expectations
• PIC/S GMP compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely TFDA deficiency & technical query triggers
✔️ You receive a clear, actionable gap-assessment report before official submission.
🧪 TFDA Submission & Taiwan Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in Taiwan, including:
• TFDA drug registration submissions
• API technical file linkage
• Finished product registration dossiers
• Import permit & customs documentation
• Post-approval change & variation support
• Regulatory coordination with local Taiwan agents
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, application, GMP & stability records
🧪 DMF / ASMF Lifecycle Management & Maintenance – Taiwan
We manage your DMF / ASMF throughout its complete regulatory lifecycle, including:
• Initial DMF / ASMF compilation
• Post-approval variations & renewals
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (long-term & accelerated)
• Specification & analytical method revisions
• Authority-driven post-approval changes
🧪 Post-Submission Deficiency & Query Handling – Taiwan
Complete post-submission regulatory support, including:
• TFDA deficiency letters & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Taiwan MAHs & importers
• Coordination between manufacturer, applicant & TFDA
🎯 Goal: Faster approvals, fewer objections, and TFDA-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for Taiwan?
🧪 Strong expertise in TFDA & Taiwan regulatory pathways
🧪 Proven experience with PIC/S GMP & ICH-aligned DMF / ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong post-submission deficiency response expertise
🧪 Seamless coordination with Taiwan importers & MAHs
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Taiwan
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient suppliers
• Packaging material suppliers
• Importers & distributors
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – Taiwan
• Taiwan Pharmaceutical Affairs Act
• TFDA Drug Registration Guidelines
• PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• Taiwan Pharmacopoeia
• USP / BP / Ph. Eur. (as accepted)
Your Trusted Partner for DMF / ASMF Excellence in Taiwan
Whether you are registering a product in Taiwan, submitting an API technical file, supporting import approvals, or responding to TFDA regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Taiwanese pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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