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