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