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