Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Argentina
Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Argentina
ANMAT-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 Argentina’s regulatory framework.
Our DMF services are designed to meet the expectations of the National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina, and align with:
• Argentine Medicinal Products Law & ANMAT Regulations
• MERCOSUR GMP Standards (aligned with WHO-GMP)
• ICH Guidelines
• CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) approvals
• Import 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 Argentina.
Our Core DMF Services – Argentina
🧪 DMF Preparation – Open & Closed Parts (Argentina–Compliant)
We prepare complete, structured, and ANMAT-aligned DMF dossiers strictly following the CTD format accepted for Argentine regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to ANMAT / Local Marketing Authorization Holders (MAH) / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product Registration (Registro de Especialidad Medicinal)
– Import Authorization
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Argentina and MERCOSUR markets
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 (PQS)
• Stability data as per Argentina climatic conditions (Zone II & IVa, as applicable)
✅ Confidential data is disclosed only to ANMAT regulators and is never shared with applicants or third parties.
DMF Types Covered – Argentina
We support CTD-based 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 – Argentina
Already have a DMF for Argentina?
We conduct an Argentina-specific DMF review and regulatory risk assessment based on:
• ANMAT expectations and regulatory audit observations
• MERCOSUR-GMP & WHO-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely ANMAT deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 ANMAT Submission & Argentina Regulatory Support
We provide hands-on support for DMF usage and registration filing in Argentina, including:
• ANMAT submissions and regulatory clarifications
• API registration support
• Import registration dossiers
• GMP & manufacturing documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, product registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Argentina
We manage your DMF throughout its complete regulatory lifecycle in Argentina, including:
• Initial DMF compilation
• Annual updates, renewals & variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• ANMAT-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – ANMAT
Complete post-submission regulatory support for Argentina, including:
• ANMAT deficiency letters & technical queries
• Scientific justification & deficiency response drafting
• Revised Open & Closed Part submissions
• Alignment with MAH / local applicant responses
• Coordination between manufacturer, MAH, and ANMAT
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Argentina?
🧪 In-depth knowledge of ANMAT & Argentine regulatory pathways
🧪 Expertise in MERCOSUR-GMP, WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong ANMAT deficiency response experience
🧪 Seamless coordination with Argentine MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Argentina
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Argentina
• ANMAT Regulations & Argentine Medicinal Products Law
• MERCOSUR GMP Standards
• WHO-GMP Compliance
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO & PAHO Technical Reports
Your Trusted Partner for DMF Excellence in Argentina
Whether you are preparing a new DMF, updating an existing dossier, supporting an ANMAT submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Argentine and MERCOSUR pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven