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