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