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