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