Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Angola
ANAMED Angola–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 Angola’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Agência Nacional de Medicamentos e Tecnologias de Saúde (ANAMED), Ministry of Health, Angola and comply with:
Angolan Medicines Law & Public Health Regulations
ANAMED Drug Registration Guidelines
GMP Guidelines accepted by Angola
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & 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 Angola.
Our Core DMF Services – Angola
🧪 DMF Preparation – Open & Closed Parts (Angola-Compliant)
We prepare complete, structured, and ANAMED-aligned DMF dossiers following the CTD format accepted for Angola submissions.
Applicant’s Part (Open Part)
Prepared for submission to ANAMED Angola / 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 License & Marketing Authorization
• CTD-structured documentation suitable for Angola 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 Angola
✅ Confidential data is disclosed strictly to ANAMED regulators and never to local applicants or distributors.
DMF Types Covered – Angola
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 – Angola
Already have a DMF for Angola?
We conduct Angola-specific DMF review and risk assessment based on:
• ANAMED technical expectations & inspection practices
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely ANAMED deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 ANAMED Submission & Angola Regulatory Support
We provide hands-on support for DMF usage and filing in Angola, including:
• ANAMED submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, ANAMED dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Angola
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and post-approval variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• ANAMED-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – ANAMED Angola
Complete post-submission regulatory support for Angola, including:
• ANAMED 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 ANAMED authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Angola?
🧪 In-depth knowledge of ANAMED Angola regulatory pathways
🧪 Expertise in Angola GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong ANAMED deficiency response experience
🧪 Seamless coordination with Angolan MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Angola
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Angola
• Angolan Medicines Law & Public Health Code
• ANAMED Angola Guidelines
• GMP Regulations accepted in Angola
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Angola
Whether you are preparing a new DMF, updating an existing dossier, supporting an ANAMED Angola submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Angolan market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven