Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Kenya
PPB-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 Kenya’s regulatory framework.
Our DMF services are designed to meet the expectations of the Pharmacy and Poisons Board (PPB), Kenya and align with:
• Pharmacy and Poisons Act (Cap 244), Kenya
• PPB Guidelines for Registration of Medicinal Products
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
• East African Community (EAC) Harmonized Registration Guidelines
Used for:
• API registration
• Finished formulation product registration
• Import permit 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 regulatory compliance, confidentiality, and smooth approval processing in Kenya.
Our Core DMF Services – Kenya
🧪 DMF Preparation – Open & Closed Parts (Kenya-Compliant)
We prepare complete, structured, and PPB-aligned DMF dossiers following CTD format accepted for Kenyan submissions.
Applicant’s Part (Open Part)
Prepared for submission to PPB Kenya / Local Marketing Authorization Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product registration
– Import permit applications
– Marketing authorization
• CTD-structured documentation suitable for Kenya and EAC markets
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 pharmaceutical quality systems
• Stability data as per WHO Climatic Zone IVa/IVb (hot & humid – applicable to Kenya)
✅ Confidential information is shared only with PPB regulators and never with applicants.
DMF Types Covered – Kenya
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredient (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Kenya
Already have a DMF for Kenya?
We conduct Kenya-specific DMF review and risk assessment based on:
• PPB regulatory expectations and inspection observations
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely PPB technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 PPB Submission & Kenya Regulatory Support
We provide hands-on support for DMF usage and filing in Kenya, including:
• PPB submissions and technical clarifications
• API registration support
• Import permit dossier preparation
• Finished product registration documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and manufacturing documents
🧪 DMF Lifecycle Management & Maintenance – Kenya
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and regulatory renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (accelerated & long-term)
• Specification and analytical method revisions
• PPB-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – PPB Kenya
Complete post-submission regulatory support, including:
• PPB deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and PPB authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Kenya?
🧪 In-depth knowledge of PPB & EAC regulatory pathways
🧪 Strong expertise in WHO GMP and ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven experience in regulatory deficiency responses
🧪 Seamless coordination with Kenyan importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Kenya
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Kenya
• Pharmacy and Poisons Act (Cap 244) – Kenya
• PPB Kenya Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• EAC Harmonized Technical Guidelines (where applicable)