Regulatory And Research Services for Cuba
🇨🇺 Regulatory and Research Services for Cuba – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research solutions to pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Cuban market.
Our services ensure full compliance with the Cuban Ministry of Public Health – Center for State Control of Medicines, Equipment, and Medical Devices (CECMED) regulations, national standards, and international ICH/WHO guidelines.
📘 Regulatory Services for Cuba
Regulatory & Product Registration Support – Cuba
We assist pharmaceutical, nutraceutical, and cosmetic companies at every stage of regulatory submission and product approval in Cuba, ensuring a smooth market entry and full compliance with CECMED guidelines.
📘 Product Registration Services
• Preparation and submission of export registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on local labeling, packaging requirements, and product information leaflets.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for Cuba registration.
• Support in API regulatory documentation, including quality, safety, and stability data.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in CECMED-approved CROs.
• Preparation of complete BE study reports in accordance with WHO and Cuban regulatory requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods as per ICH Q2(R2) guidelines.
• Preparation of AMV documentation for regulatory submission and routine QC support.
🧾 Regulatory Consultancy & Compliance
• Comprehensive regulatory guidance for export or local market entry in Cuba.
• Assistance with import/export permissions, CECMED inspections, and post-approval compliance.
• Regular updates on CECMED and WHO regulatory changes to ensure continuous product compliance.
🧪 Research & Development (R&D) Services – Cuba
Our R&D services support your product development, validation, and quality assurance activities in compliance with Cuba’s CECMED and international standards.
💊 Formulation Development
• Development of tablets, capsules, syrups, powders, and injectables.
• Optimization for stability, bioavailability, and efficacy suited to regional conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Quality control method development and routine analytical testing.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for regulatory submission.
• Inclusion of manufacturing process, QC methods, and stability data in line with CECMED requirements.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols and final study reports.
• Toxicological evaluation in compliance with OECD and CECMED guidelines.
🌏 Why Choose Us for the Cuban Market
• Experienced Team – Experts in CECMED, WHO, and ICH regulatory frameworks.
• End-to-End Support – From formulation development to market registration and post-approval compliance.
• Global Exposure – Proven experience across ROW, ASEAN, US, and EU markets.
• Timely Submissions – Streamlined processes ensuring faster approvals.
• Custom Solutions – Tailored strategies for your product type, market, and regulatory pathway.
📘 Regulatory & Dossier Documentation – Cuba
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⚗️ Bioequivalence & Analytical Studies – Cuba
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🧪 Technology Transfer & Safety – Cuba
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