Drug Master File (DMF) Preparation, Review & Regulatory Support Services – United States (USA)
US FDA–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 the United States regulatory framework.
Our DMF services are designed to meet the expectations of the U.S. Food and Drug Administration (US FDA)—specifically CDER (Center for Drug Evaluation and Research)—and fully align with:
• U.S. Federal Food, Drug & Cosmetic Act (FD&C Act)
• 21 CFR Parts 210, 211, 314 & 820 (as applicable)
• ICH Guidelines (Q, M, and E Series)
• eCTD-based electronic submissions used for:
• API registration & referencing
• ANDA & NDA support
• IND submissions
• Importation & drug listing support
• Global 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 US FDA review and approval processing.
Our Core DMF Services – United States
🧪 DMF Preparation – Open & Closed Parts (US FDA–Compliant)
We prepare complete, structured, and FDA-aligned DMF dossiers strictly following the US DMF format and eCTD structure required by the FDA.
Applicant’s Part (Open Part)
Prepared for submission to US FDA / ANDA & NDA Applicants / IND Sponsors, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– ANDA (Abbreviated New Drug Application)
– NDA (New Drug Application)
– IND (Investigational New Drug Application)
– Drug Listing & Import Filings
• eCTD-ready documentation suitable for US and global regulatory use
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process & process flow diagrams
• Critical process parameters (CPPs) & in-process controls (IPCs)
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2(R2))
• Control strategy & Pharmaceutical Quality System (ICH Q10)
• Stability data as per US FDA climatic zone requirements (Zone II & IVa/IVb, as applicable)
✅ Confidential information is disclosed only to US FDA and is never shared with applicants.
US FDA DMF Types Covered
We support preparation and maintenance of all official US FDA DMF Types:
• Type II – Drug Substance (API), Drug Product, Intermediates
• Type III – Packaging Materials
• Type IV – Excipients, Colorants, Flavors, Essences
• Type V – Reference Information (Unique Manufacturing Data)
🧪 DMF Review & Gap Assessment – United States
Already have a US DMF?
We conduct a US FDA-specific DMF review and regulatory risk assessment based on:
• US FDA current expectations & audit findings
• 21 CFR & ICH compliance gaps
• eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely FDA Complete Response Letter (CRL) triggers
✔️ You receive a clear, actionable gap assessment report prior to FDA submission or inspection.
🧪 US FDA Submission & Regulatory Support
We provide hands-on support for DMF filing and usage with the US FDA, including:
• New DMF submissions (eCTD format)
• Letters of Authorization (LOA) preparation
• ANDA / NDA / IND cross-referencing
• Facility registration & drug listing support
• Import documentation & US agent coordination
• Global export-linked FDA DMF alignment
Our team ensures:
• Correct eCTD formatting
• Accurate cross-referencing via LOAs
• Full consistency across DMF, ANDA/NDA, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – United States
We manage your DMF throughout its complete regulatory lifecycle with the US FDA, including:
• Initial DMF compilation & submission
• DMF annual updates (AUs)
• Manufacturing site changes & supplements
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• US FDA-driven amendments and deficiency updates
🧪 Post-Submission Deficiency & Query Handling – US FDA
Complete post-submission regulatory support for US DMFs, including:
• FDA DMF deficiency letters
• Complete Response Letter (CRL) support
• Scientific justification & technical query response drafting
• Revised Open & Closed Part submissions
• Alignment with ANDA / NDA applicants
• Coordination between manufacturer, sponsor, and US FDA
🎯 Goal: Faster approvals, zero-defect submissions, and regulator-ready DMFs for the US market.
🧪 Why Choose DMF Direct for the United States?
🧪 In-depth knowledge of US FDA DMF & ANDA/NDA pathways
🧪 Expertise in 21 CFR, ICH & US-specific quality systems
🧪 Secure handling of high-value confidential manufacturing data
🧪 Strong FDA deficiency & CRL response experience
🧪 Seamless coordination with US applicants, sponsors & agents
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – United States
• Global API manufacturers
• Finished dosage form (FDF) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• US importers & CMOs
• Drug development & biotech firms
• ANDA / NDA sponsor companies
Regulatory Standards Followed – United States
• US Federal Food, Drug & Cosmetic Act
• 21 CFR Parts 210, 211, 314
• US FDA DMF Guidance
• ICH Q-Series, M-Series & E-Series Guidelines
• eCTD Module 2 & Module 3 Documentation
• WHO & FDA Technical Reports
Your Trusted Partner for DMF Excellence in the United States
Whether you are preparing a new US DMF, supporting an ANDA / NDA filing, responding to FDA deficiencies, or managing DMF lifecycle updates, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the United States pharmaceutical market.
✅ US FDA–aligned
✅ Fully confidential
✅ eCTD-ready
✅ Approval-driven