GlobalCOA – Sri Lanka 🇱🇰

Certificate of Analysis (COA) Preparation, Review & Testing Services

Sri Lanka-Compliant COAs. Regulatory-Ready. Export-Focused.

GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Sri Lankan regulatory requirements for products manufactured, marketed, or exported to or from Sri Lanka.

We support Sri Lankan manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Sri Lanka Standards (SLS) and seamless acceptance in domestic and international markets.

🏛️ Regulatory Framework – Sri Lanka

GlobalCOA services are aligned with the requirements of key Sri Lankan regulatory and standards authorities:

  • National Medicines Regulatory Authority (NMRA): The principal authority under the Ministry of Health (MOH) responsible for regulating Medicines, Medical Devices, and Borderline Products (e.g., some health supplements) under the NMRA Act No. 5 of 2015. NMRA approval is mandatory for market access.

  • Sri Lanka Standards Institution (SLSI): The National Standards Body, responsible for developing and publishing Sri Lanka Standards (SLS) and operating mandatory and voluntary product certification schemes (the SLS Mark). SLS compliance is mandatory for many imported and locally manufactured items.

  • Food Safety and Quality Assurance (FSQA) Division / Ministry of Health: Responsible for regulating Food Products, Ingredients, and Safety under the Food Act No. 26 of 1980 and its regulations.

  • Sri Lanka Accreditation Board (SLAB): The national body for accrediting testing laboratories (ISO/IEC 17025).

  • International Pharmacopoeia / Standards: Sri Lankan regulations often reference international standards:

    • BP / USP / EP / IP: Referenced for pharmaceutical quality.

    • Codex Alimentarius: Referenced for food safety and quality standards.

🔬 Our GlobalCOA Services – Sri Lanka

We offer complete lifecycle support for Certificate of Analysis documentation as per Sri Lankan regulatory expectations:

✅ COA Preparation (Sri Lanka-Compliant)

  • COA drafting aligned with NMRA requirements (for Drug Registration/Import License), Food Act Regulations, and mandatory Sri Lanka Standards (SLS) set by SLSI.

  • Compliance with international pharmacopoeias (IP / USP / BP / EP) for drugs and Codex standards for food.

  • Batch-wise, stability-based, and customer-specific COAs.

  • COAs suitable for NMRA Product Registration, Import Control, and SLS Mark Certification.

✅ COA Review & Regulatory Compliance Assessment

  • Review of existing COAs for NMRA / FSQA / SLSI / SLS compliance.

  • Identification and correction of non-compliance issues:

    • Missing mandatory parameters (e.g., as per specific SLS standards or NMRA requirements).

    • Incorrect acceptance criteria or non-approved test methods.

  • Harmonization with product specifications and registration dossiers submitted to the NMRA.

✅ Testing & Analytical Coordination (Sri Lanka)

  • Testing coordination through SLAB-accredited (ISO/IEC 17025) or internationally recognized laboratories.

  • Method selection as per:

    • Relevant Pharmacopoeial methods (IP, BP, USP) for medicines.

    • Sri Lanka Standards (SLS) / FSQA methods or Codex Alimentarius for food and other regulated products.

    • Validated in-house methods with appropriate justification.

  • Support for re-testing, OOS/OOT investigations, and quality trend analysis.

📦 Product Categories Covered – Sri Lanka

GlobalCOA provides COA services for regulated sectors:

  • 🔹 Medicines & Health Products

    • APIs, Finished Drugs, and Excipients (regulated by NMRA).

    • Traditional, Ayurvedic, and Herbal Medicines.

  • 🔹 Food & Beverages

    • Processed Food, Food Ingredients, and Nutritional Products (regulated by FSQA).

  • 🔹 Cosmetics & Personal Care

    • Products regulated under relevant health and trade regulations.

  • 🔹 Industrial & Consumer Products

    • Materials requiring mandatory SLS Mark Certification.

🏭 Industries We Serve – Sri Lanka

GlobalCOA supports regulated industries targeting the Sri Lankan market, including:

  • Pharmaceuticals & APIs Suppliers

  • Ayurvedic/Herbal Product Manufacturers

  • Food & Beverage Exporters/Manufacturers

  • Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Sri Lanka?

  • **✔ Deep understanding of NMRA and mandatory SLSI/SLS Standards.

  • COAs aligned with major international standards (IP/BP/USP/Codex) and SLS.

  • Strong coordination with SLAB-accredited and international laboratories.

  • Documentation suitable for NMRA Registration and SLS Certification.

📝 Regulatory & Export Support – Sri Lanka

GlobalCOA COAs support critical processes in the Sri Lankan context:

  • Product Registration applications to the NMRA (Medicines).

  • Import License applications and customs clearance (especially for food and drugs).

  • Compliance with mandatory Sri Lanka Standards (SLS) for local market access.

  • Supporting documentation for GMP compliance and quality assurance.

Our Sri Lanka-focused COAs reduce regulatory delays and ensure efficient market access.

📞 Get Started with GlobalCOA – Sri Lanka

Whether you require new COA preparation, review of existing COAs, or testing support for Sri Lankan manufacturing, import, or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.