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