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