Regulatory And Research Services for Kenya
🇰🇪 Regulatory and Research Services for Kenya – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Kenya market.
Our services ensure full compliance with the Pharmacy and Poisons Board (PPB Kenya), as well as WHO and ICH guidelines.
📘 Regulatory Services for Kenya
Regulatory & Product Registration Support – Kenya
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with PPB Kenya, ensuring smooth market access and full regulatory compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets according to PPB Kenya regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Kenya.
• Support in preparing quality, safety, and stability documentation in line with PPB Kenya and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in PPB-approved CROs.
• Preparation of BE study protocols and reports according to WHO and PPB Kenya requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Kenya market.
• Assistance with import/export licensing, PPB Kenya inspections, renewals, and post-approval compliance.
• Continuous updates on PPB Kenya regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Kenya
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with PPB Kenya and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Kenya’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per PPB Kenya requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to PPB Kenya.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicology studies according to OECD and WHO guidelines for PPB Kenya submission.
🌏 Why Choose Us for the Kenya Market
• Experienced Regulatory Experts – Skilled in PPB Kenya, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across East Africa.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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