Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Chad

ANMPS Chad–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 Chad’s pharmaceutical regulatory framework.

Our DMF services are designed to meet the requirements of the National Agency for Medicines and Health Products (ANMPS), Ministry of Public Health, Chad and comply with:

• Chadian Public Health Code

• ANMPS Drug Registration Guidelines

• CEMAC Pharmaceutical Regulations

• GMP Guidelines accepted in Chad (WHO GMP aligned)

• 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:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing in Chad.

Our Core DMF Services – Chad

🧪 DMF Preparation – Open & Closed Parts (Chad-Compliant)

We prepare complete, structured, and ANMPS-aligned DMF dossiers following the CTD format accepted for Chad submissions.

Applicant’s Part (Open Part)

Prepared for submission to ANMPS Chad / 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 Chad and CEMAC-linked 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 Chad

✅ Confidential data is disclosed strictly to ANMPS regulators and never to local applicants or distributors.

DMF Types Covered – Chad

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 – Chad

Already have a DMF for Chad?

We conduct Chad-specific DMF review and risk assessment based on:

• ANMPS technical expectations & inspection practices
• WHO-GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely ANMPS deficiency triggers

✔️ You receive a clear, actionable gap assessment report before submission or inspection.

🧪 ANMPS Submission & Chad Regulatory Support

We provide hands-on support for DMF usage and filing in Chad, including:

• ANMPS submissions and clarifications
• API registration support
• Finished product registration support
• Import authorization & marketing authorization dossiers
• CEMAC export-linked DMF alignment

Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, ANMPS dossiers, and manufacturing records

🧪 DMF Lifecycle Management & Maintenance – Chad

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
• ANMPS-driven amendments and updates

🧪 Post-Submission Deficiency & Query Handling – ANMPS Chad

Complete post-submission regulatory support for Chad, including:

• ANMPS 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 ANMPS authority

🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.

🧪 Why Choose DMF Direct for Chad?

🧪 In-depth knowledge of ANMPS & CEMAC regulatory pathways
🧪 Expertise in WHO GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong ANMPS deficiency response experience
🧪 Seamless coordination with Chadian MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength

Industries We Support – Chad

• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)

Regulatory Standards Followed – Chad

• Chad Public Health Code
• ANMPS Drug Registration Guidelines
• CEMAC Pharmaceutical Regulations
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation

Your Trusted Partner for DMF Excellence in Chad

Whether you are preparing a new DMF, updating an existing dossier, supporting a Chad ANMPS submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Chadian market.

✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven