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