Drug Master File (DMF) Preparation, Review & Regulatory Support Services – China
NMPA / CDE–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for China’s regulatory framework.
Our DMF services are designed to meet the expectations of:
National Medical Products Administration (NMPA), China
Center for Drug Evaluation (CDE), China
And comply with:
Chinese Drug Administration Law
NMPA Registration Measures for Drugs
China GMP (2010 & Updated Guidelines)
ICH Guidelines (China is ICH member)
CTD-based technical dossier formats used for:
• API registration & technical review in China
• Finished formulation (Drug Product) registration
• Import drug registration dossiers
• MAH-linked regulatory filings
• Export-oriented China regulatory submissions
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 with NMPA & CDE.
Our Core DMF Services – China
🧪 DMF Preparation – Open & Closed Parts (China-Compliant)
We prepare complete, structured, and CDE-aligned DMF dossiers following CTD formats accepted for Chinese drug registrations.
Applicant’s Part (Open Part)
Prepared for submission to NMPA / CDE / Chinese MAHs, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– Drug Registration Application (IND / NDA / ANDA-equivalent)
– Imported Drug Registration
– MAH Licensing Support
– Local Agent & Distributor Submissions
• CTD-structured documentation suitable for China and global submissions
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing processes & process flow diagrams
• Critical process parameters & in-process controls
• Raw material, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2 + Chinese Pharmacopoeia)
• Control strategy & pharmaceutical quality system (PQS)
• Stability data as per China climatic conditions (Climatic Zone II & IV where applicable)
✅ Confidential data is disclosed only to NMPA / CDE reviewers — not to applicants or commercial partners.
DMF Types Covered – China
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (APIs), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – China
Already have a DMF for China?
We conduct China-specific DMF review and regulatory risk assessment based on:
• CDE technical review expectations
• China GMP compliance gaps
• CTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely CDE deficiency & technical query triggers
✔️ You receive a clear, actionable gap assessment report before CDE submission or on-site inspection.
🧪 NMPA / CDE Submission & China Regulatory Support
We provide hands-on support for DMF filing and regulatory usage in China, including:
• NMPA / CDE submissions & clarifications
• API registration technical file support
• Imported drug registration dossiers
• MAH-linked documentation
• Export-linked DMF alignment for China market entry
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, registration dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – China
We manage your DMF through its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• CDE-driven amendments & post-approval changes
🧪 Post-Submission Deficiency & Query Handling – China
Complete post-submission regulatory support, including:
• CDE technical deficiency letters
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with Chinese MAH & local agent responses
• Coordination between manufacturer, Chinese partner & authority
🎯 Goal: Faster approvals, fewer queries, and CDE-ready DMF documentation.
🧪 Why Choose DMF Direct for China?
🧪 Deep expertise in NMPA & CDE regulatory pathways
🧪 Strong experience with China GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven CDE deficiency & technical query response success
🧪 Seamless coordination with Chinese MAHs, importers & agents
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – China
• API manufacturers
• Finished formulation (FDF) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• Importers & MAHs in China
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – China
• China Drug Administration Law
• NMPA & CDE Technical Guidelines
• China GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• Chinese Pharmacopoeia (ChP) alignment
• WHO-GMP & global regulatory standards (where applicable)
Your Trusted Partner for DMF Excellence in China
Whether you are preparing a new DMF, updating an existing Chinese technical file, supporting a CDE submission, transferring technology to a China MAH, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Chinese market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
If you want, I can also prepare:
✅ Chinese-localized (Mandarin) version for NMPA agents
✅ SEO landing page for “DMF Services for China”
✅ Export-focused China DMF services page for Indian API & FDF companies