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

ZAMRA-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 Zambia’s regulatory framework.

Our DMF services are designed to meet the expectations of the Zambia Medicines Regulatory Authority (ZAMRA) and align with the Medicines and Allied Substances Act, WHO GMP, ICH Guidelines, and CTD-based submissions used for:

• API registration

• Finished formulation (FPP) approvals

• Import permit and marketing authorization dossiers

• Export-oriented regulatory filings within SADC / ZAZIBONA markets

We specialize in the preparation and maintenance of both:

1. Open Part (Applicant’s Part)

2. Closed Part (Restricted / Confidential Part)

Ensuring regulatory compliance, confidentiality, and smooth approval processing in Zambia.

Our Core DMF Services – Zambia

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

We prepare complete, structured, and ZAMRA-aligned DMF dossiers following CTD format accepted for Zambian submissions.

Applicant’s Part (Open Part)

Prepared for submission to ZAMRA / Local Applicants / Marketing Authorization Holders, including:

• Quality Overall Summary (QOS) aligned with ICH Q2–Q6

• Non-confidential manufacturing and quality information

• Cross-reference-ready content for:
  – Finished product registration
  – Import permit / marketing authorization

• CTD-structured documentation suitable for Zambia and regional exports (SADC / ZAZIBONA)

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 material, intermediates, and finished product specifications

• Analytical methods and method validation (ICH Q2)

• Control strategy and quality assurance systems

• Stability data as per WHO Climatic Zone IVb / IVa (hot conditions applicable to Zambia)

✅ Confidential content is protected and disclosed only to ZAMRA regulators, not applicants.

DMF Types Covered – Zambia

We support DMF documentation for:

• Type II – Active Pharmaceutical Ingredients (APIs), Intermediates

• Type III – Packaging Materials

• Type IV – Excipients

• Type V – Reference / Miscellaneous Information

🧪 DMF Review & Gap Assessment – Zambia

Already have a DMF for Zambia?
We conduct Zambia-specific DMF review and risk assessment based on:

• ZAMRA expectations and typical inspection / review observations

• WHO GMP and Medicines & Allied Substances Act compliance gaps

• CTD structure and content deficiencies

• Manufacturing, validation, and stability inconsistencies

• Likely ZAMRA deficiency triggers

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

🧪 ZAMRA Submission & Zambia Regulatory Support

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

• ZAMRA submissions and technical clarifications

• API registration support

• Import permit and product registration dossiers

• Export-linked DMF alignment for SADC / ZAZIBONA procedures

Our team ensures:

• Correct CTD formatting

• Accurate cross-referencing between DMF, product dossier, and forms

• Consistency across DMF, application, and manufacturing records

🧪 DMF Lifecycle Management & Maintenance – Zambia

We manage your DMF throughout its complete regulatory lifecycle, including:

• Initial DMF compilation

• Annual updates and renewals

• Manufacturing site changes and additions

• Process optimization or scale-up documentation

• Stability updates (real-time & accelerated)

• Specification and analytical method revisions

• ZAMRA-driven amendments and updates

🧪 Post-Submission Deficiency & Query Handling – ZAMRA

Complete post-submission regulatory support for Zambia, including:

• ZAMRA deficiency letters and technical queries

• Scientific justification and response drafting

• Revised Open & Closed Part submissions

• Alignment with applicant / MAH responses

• Coordination between manufacturer, applicant, and ZAMRA

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

🧪 Why Choose DMF Direct for Zambia?

• In-depth knowledge of ZAMRA & regional SADC/ZAZIBONA pathways

• Expertise in WHO GMP and ICH-aligned DMF documentation

• Secure handling of confidential manufacturing information

• Strong experience in regulatory deficiency response and inspections support

• Seamless coordination with Zambian applicants and license holders

• Backed by Zoesoe Exports Pvt Ltd’s regulatory and technical strength

Industries We Support – Zambia

• API manufacturers

• Finished formulation manufacturers (FDF)

• Excipient manufacturers

• Packaging material suppliers

• Importers and exporters

• Contract manufacturing organizations (CMOs)

Regulatory Standards Followed – Zambia

• Medicines and Allied Substances Act – Zambia

• ZAMRA Guidelines for Medicines Registration

• WHO GMP

• ICH Q-Series & M-Series Guidelines

• CTD / eCTD-ready documentation

• SADC / ZAZIBONA technical and procedural guidance (where applicable)

Your Trusted Partner for DMF Excellence in Zambia

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

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