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