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