Regulatory And Research Services for Nepal
🇳🇵 Regulatory and Research Services for Nepal – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research solutions for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Nepal market.
Our services ensure full compliance with the Department of Drug Administration (DDA), Ministry of Health and Population, Nepal, as well as WHO and ICH guidelines.
📘 Regulatory Services for Nepal
Regulatory & Product Registration Support – Nepal
We assist pharmaceutical, nutraceutical, and cosmetic companies at every stage of regulatory submission and product registration with DDA Nepal, ensuring smooth market entry and full compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets per DDA Nepal requirements.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Nepal.
• Support in preparation of quality, safety, and stability documentation in line with DDA Nepal and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in DDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and DDA Nepal requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods as per ICH Q2(R2) guidelines.
• Preparation of AMV documentation for regulatory submission and routine QC support.
🧾 Regulatory Consultancy & Compliance
• Comprehensive regulatory guidance for entry into the Nepal market.
• Assistance with import/export licenses, DDA Nepal inspections, renewals, and post-approval compliance.
• Continuous updates on DDA Nepal regulatory changes to ensure ongoing product compliance.
🧪 Research & Development (R&D) Services – Nepal
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with DDA Nepal and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Nepalese climatic conditions to ensure product efficacy.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories as per DDA Nepal requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to DDA Nepal.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicological studies according to OECD and WHO guidelines for DDA Nepal submission.
🌏 Why Choose Us for the Nepal Market
• Experienced Regulatory Experts – Skilled in DDA Nepal, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Experience across South Asia and ASEAN markets.
• 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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