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