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