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