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