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