GlobalCOA – Thailand 🇹🇭
Certificate of Analysis (COA) Preparation, Review & Testing Services
Thailand-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 Thai regulatory requirements for products manufactured, marketed, or exported from Thailand.
We support Thai manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Thai Industrial Standards (TIS) and seamless acceptance in domestic and international markets.
🏛️ Regulatory Framework – Thailand
GlobalCOA services are aligned with the requirements of key Thai regulatory and standards authorities:
Food and Drug Administration (FDA) Thailand: The principal regulatory body under the Ministry of Public Health (MOPH) responsible for the registration, quality, and safety control of Drugs (Pharmaceuticals), Food, Cosmetics, and Medical Devices. FDA approval (Registration/Notification/License) is mandatory for market access.
Thai Industrial Standards Institute (TISI): The National Standards Body under the Ministry of Industry (MOI) responsible for developing and publishing Thai Industrial Standards (TIS) and implementing mandatory product certification (TIS Mark) for various industrial and consumer products.
National Bureau of Agricultural Commodity and Food Standards (ACFS): Under the Ministry of Agriculture and Cooperatives (MOAC), ACFS is responsible for standards related to agricultural commodities and food products not directly covered by the FDA.
Thai National Accreditation System (TNAS): The national body for accreditation, ensuring testing laboratories are accredited (ISO/IEC 17025).
International/ASEAN Standards: Thai regulations and standards are highly harmonized with regional ASEAN standards and major international standards:
USP / BP / EP / ACTD: Primary standards referenced for pharmaceutical quality and documentation.
Codex Alimentarius: Referenced for food safety and quality standards.
🔬 Our GlobalCOA Services – Thailand
We offer complete lifecycle support for Certificate of Analysis documentation as per Thai regulatory expectations:
✅ COA Preparation (Thailand-Compliant)
COA drafting aligned with FDA Thailand regulations (for product registration/license), relevant Thai Industrial Standards (TIS), and technical regulations (e.g., specific contaminant limits in food).
Compliance with international pharmacopoeias (USP / BP / EP) and ACTD/ASEAN guidelines for drugs.
Batch-wise, stability-based, and customer-specific COAs.
COAs suitable for FDA Product Registration/License applications and TIS Mandatory Certification.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for FDA / TISI / TIS / ACTD compliance.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters (e.g., heavy metals, specific residues, microbial load).
Incorrect acceptance criteria or non-approved test methods.
Harmonization with product specifications and registration dossiers submitted to the FDA.
✅ Testing & Analytical Coordination (Thailand)
Testing coordination through TNAS-accredited (ISO/IEC 17025) or FDA/TISI-recognized laboratories.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) or methods recognized under the ACTD for drugs.
Thai Industrial Standards (TIS) / FDA 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 – Thailand
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products
APIs, Traditional Medicines, and Health Supplements (regulated by FDA).
Finished Drug Products.
🔹 Food & Beverages
Processed Food, Food Ingredients, and Nutritional Products (regulated by FDA and ACFS/MOAC).
🔹 Cosmetics & Personal Care
Products regulated under FDA Cosmetic Regulations (referencing ASEAN Cosmetic Directive).
🔹 Industrial & Other Products
Materials requiring mandatory TISI Certification (TIS Mark) or compliance with TIS.
🏭 Industries We Serve – Thailand
GlobalCOA supports regulated Thai industries including:
Pharmaceuticals & Traditional Medicines
Food Processing & Beverage
Cosmetics & Personal Care
Industrial Manufacturing and Trading
🌟 Why Choose GlobalCOA for Thailand?
**✔ Deep understanding of FDA Thailand and TISI requirements.
✔ COAs aligned with Thai Industrial Standards (TIS) and ACTD/ASEAN guidelines.
✔ Strong coordination with TNAS-accredited laboratories.
✔ Documentation suitable for FDA Registration/License applications and TIS certification.
📝 Regulatory & Export Support – Thailand
GlobalCOA COAs support critical processes in the Thai context:
Product Registration/License applications to the FDA (Drugs, Food, Cosmetics).
Customs clearance and import/export documentation.
Compliance with TISI Mandatory Certification Schemes.
Supporting documentation for GMP compliance and quality audits.
Our Thailand-focused COAs reduce regulatory delays and ensure efficient market access across the ASEAN region.
📞 Get Started with GlobalCOA – Thailand
Whether you require new COA preparation, review of existing COAs, or testing support for Thai manufacturing or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.