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