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