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