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