Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Uruguay
MSP Uruguay–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 Uruguay’s regulatory framework.
Our DMF services are designed to meet the expectations of the Ministry of Public Health (MSP), Uruguay, through the National Medicines Agency (Dirección Nacional de Medicamentos) and align with:
• Uruguay Medicines Law & MSP Regulations
• MERCOSUR GMP Standards (aligned with WHO-GMP)
• WHO & 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 Uruguay.
Our Core DMF Services – Uruguay
🧪 DMF Preparation – Open & Closed Parts (Uruguay–Compliant)
We prepare complete, structured, and MSP-aligned DMF dossiers strictly following the CTD format accepted for Uruguayan regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to MSP / 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 Farmacéutica)
– Import Authorization
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Uruguay 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 Uruguay climatic conditions (Zone II)
✅ Confidential data is disclosed only to MSP regulators and is never shared with applicants or third parties.
DMF Types Covered – Uruguay
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 – Uruguay
Already have a DMF for Uruguay?
We conduct a Uruguay-specific DMF review and regulatory risk assessment based on:
• MSP expectations and regulatory audit observations
• MERCOSUR-GMP & WHO-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely MSP deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 MSP Submission & Uruguay Regulatory Support
We provide hands-on support for DMF usage and registration filing in Uruguay, including:
• MSP 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 – Uruguay
We manage your DMF throughout its complete regulatory lifecycle in Uruguay, 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
• MSP-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – MSP
Complete post-submission regulatory support for Uruguay, including:
• MSP 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 MSP
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Uruguay?
🧪 In-depth knowledge of Uruguay MSP & MERCOSUR regulatory pathways
🧪 Expertise in MERCOSUR-GMP, WHO-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong MSP deficiency response experience
🧪 Seamless coordination with Uruguayan MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Uruguay
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Uruguay
• Uruguay Medicines Law & MSP Regulations
• 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 Uruguay
Whether you are preparing a new DMF, updating an existing dossier, supporting an MSP submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Uruguayan and MERCOSUR pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven