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