Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Mexico
COFEPRIS-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 Mexico’s regulatory framework.
Our DMF services are designed to meet the expectations of the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico, under the Ministry of Health (Secretaría de Salud) and align with:
• General Health Law of Mexico (Ley General de Salud)
• Regulation of Health Supplies (Reglamento de Insumos para la Salud)
• Good Manufacturing Practices (GMP)
• ICH & WHO 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 Mexico.
Our Core DMF Services – Mexico
🧪 DMF Preparation – Open & Closed Parts (Mexico–Compliant)
We prepare complete, structured, and COFEPRIS-aligned DMF dossiers strictly following the CTD format accepted for Mexican regulatory submissions.
Applicant’s Part (Open Part)
Prepared for submission to COFEPRIS / 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:
– Marketing Authorization (Registro Sanitario)
– Import Authorization
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Mexico and Latin American 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 Mexico climatic conditions (Zones II & IVa, as applicable)
✅ Confidential data is disclosed only to COFEPRIS regulators and is never shared with applicants or third parties.
DMF Types Covered – Mexico
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 – Mexico
Already have a DMF for Mexico?
We conduct a Mexico-specific DMF review and regulatory risk assessment based on:
• COFEPRIS expectations and inspection observations
• GMP & NOM compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely COFEPRIS deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 COFEPRIS Submission & Mexico Regulatory Support
We provide hands-on support for DMF usage and registration filing in Mexico, including:
• COFEPRIS 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, sanitary registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Mexico
We manage your DMF throughout its complete regulatory lifecycle in Mexico, 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
• COFEPRIS-driven amendments and compliance updates
🧪 Post-Submission Deficiency & Query Handling – COFEPRIS
Complete post-submission regulatory support for Mexico, including:
• COFEPRIS 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 COFEPRIS
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Mexico?
🧪 In-depth knowledge of COFEPRIS & Mexican regulatory pathways
🧪 Expertise in GMP, NOM, WHO & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong COFEPRIS deficiency response experience
🧪 Seamless coordination with Mexican MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Mexico
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Mexico
• General Health Law of Mexico (Ley General de Salud)
• COFEPRIS Guidelines & Mexican Official Standards (NOMs)
• Good Manufacturing Practices (GMP)
• WHO & ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO & PAHO Technical Reports
Your Trusted Partner for DMF Excellence in Mexico
Whether you are preparing a new DMF, updating an existing dossier, supporting a COFEPRIS submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Mexican and Latin American pharmaceutical markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven