Regulatory And Research Services for Uganda
🇺🇬 Regulatory and Research Services for Uganda – 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 Uganda market.
Our services ensure full compliance with the National Drug Authority (NDA Uganda), as well as WHO and ICH guidelines.
📘 Regulatory Services for Uganda
Regulatory & Product Registration Support – Uganda
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with NDA Uganda, 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 NDA Uganda regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Uganda.
• Support in preparing quality, safety, and stability documentation in line with NDA Uganda and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in NDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and NDA Uganda 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 Uganda market.
• Assistance with import/export licensing, NDA Uganda inspections, renewals, and post-approval compliance.
• Continuous updates on NDA Uganda regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Uganda
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with NDA Uganda and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Uganda’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per NDA Uganda requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to NDA Uganda.
• 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 NDA Uganda submission.
🌏 Why Choose Us for the Uganda Market
• Experienced Regulatory Experts – Skilled in NDA Uganda, 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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