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