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