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