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