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