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