Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Guinea
DNPM Guinea–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Guinea’s regulatory framework.
Our DMF services are designed to meet the requirements of the National Directorate of Pharmacy and Medicines (DNPM), Ministry of Health, Guinea and comply with:
Guinean Pharmaceutical Law & Public Health Regulations
DNPM Drug Registration Guidelines
GMP Guidelines accepted in Guinea
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import authorization & marketing authorization 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 Guinea.
Our Core DMF Services – Guinea
🧪 DMF Preparation – Open & Closed Parts (Guinea-Compliant)
We prepare complete, structured, and DNPM-aligned DMF dossiers following the CTD format accepted for Guinea submissions.
Applicant’s Part (Open Part)
Prepared for submission to DNPM / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import Authorization & Marketing Authorization
• CTD-structured documentation suitable for Guinea and global exports
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone IVb climatic conditions applicable to Guinea
✅ Confidential data is disclosed strictly to DNPM regulators and never to local applicants or distributors.
DMF Types Covered – Guinea
We support 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 – Guinea
Already have a DMF for Guinea?
We conduct Guinea-specific DMF review and risk assessment based on:
• DNPM technical expectations & inspection practices
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DNPM deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DNPM Submission & Guinea Regulatory Support
We provide hands-on support for DMF usage and filing in Guinea, including:
• DNPM submissions and clarifications
• API registration support
• Finished product registration support
• Import authorization & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, DNPM dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Guinea
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DNPM-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DNPM Guinea
Complete post-submission regulatory support for Guinea, including:
• DNPM deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and DNPM authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Guinea?
🧪 In-depth knowledge of DNPM Guinea regulatory pathways
🧪 Expertise in Guinea GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DNPM deficiency response experience
🧪 Seamless coordination with Guinean MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Guinea
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Guinea
• Guinean Pharmaceutical Law & Public Health Code
• DNPM Guinea Guidelines
• GMP Regulations accepted in Guinea
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Guinea
Whether you are preparing a new DMF, updating an existing dossier, supporting a DNPM Guinea submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Guinean market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven