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