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