Regulatory And Research Services for Georgia
🇬🇪 Regulatory and Research Services for Georgia – 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 Georgia market.
Our services ensure full compliance with the Medicines and Medical Devices Agency (MMDA) under the Ministry of Health of Georgia, as well as WHO and ICH guidelines.
📘 Regulatory Services for Georgia
Regulatory & Product Registration Support – Georgia
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with MMDA Georgia, 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 MMDA Georgia regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Georgia.
• Support in preparing quality, safety, and stability documentation in line with MMDA Georgia and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in MMDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and MMDA Georgia 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 Georgia market.
• Assistance with import/export licensing, MMDA Georgia inspections, renewals, and post-approval compliance.
• Continuous updates on MMDA Georgia regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Georgia
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with MMDA Georgia and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Georgia’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per MMDA Georgia requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to MMDA Georgia.
• 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 MMDA Georgia submission.
🌏 Why Choose Us for the Georgia Market
• Experienced Regulatory Experts – Skilled in MMDA Georgia, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across the Caucasus and Eastern Europe.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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