GlobalCOA – Myanmar 🇲🇲

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

Myanmar-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 Myanmar regulatory requirements for products manufactured, marketed, or exported to or from Myanmar.

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

🏛️ Regulatory Framework – Myanmar

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

• Food and Drug Administration (FDA) Myanmar: The principal regulatory body under the Ministry of Health (MOH) responsible for the registration, quality, and safety control of Drugs (Pharmaceuticals), Food, Cosmetics, and Medical Devices. FDA approval is mandatory for production and import.

• Department of Research and Innovation (DRI) / Myanmar Standardization Council (MSC):

  • MSC: The National Standards Body, responsible for setting and publishing Myanmar Standards (MS) and developing technical regulations.

  • DRI (formerly MASB): Executes the government's standardization and metrology functions.

• MOH Central Drug Laboratory (CDL) / National Food Control Laboratory (NFCL): Official government testing facilities, whose requirements and methodology are often key references.

• Accreditation: Reliance on international accreditation bodies (e.g., ISO/IEC 17025) for testing laboratories due to limited local accredited capacity.

• International/ASEAN Standards: Myanmar often adopts or references regional ASEAN standards and major international standards due to trade obligations:

  • BP / USP / EP / ACTD: Referenced for pharmaceutical quality and documentation.

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

🔬 Our GlobalCOA Services – Myanmar

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

✅ COA Preparation (Myanmar-Compliant)

• COA drafting aligned with FDA Myanmar regulations (for product registration, import license), and applicable Myanmar Standards (MS).

• 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, Import Licensing, and customs documentation.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for FDA / MS / ACTD compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., heavy metals for food/traditional medicine, specific API assays).

  • Incorrect acceptance criteria or non-approved test methods.

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

✅ Testing & Analytical Coordination (Myanmar)

• Testing coordination through ISO/IEC 17025 accredited laboratories recognized by the FDA or international inspection agencies.

• Method selection as per:

  • Relevant Pharmacopoeial methods (BP, USP, EP) or methods recognized under the ACTD for drugs.

  • Myanmar Standards (MS) 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 – Myanmar

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

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

  • Traditional Medicines and Health Supplements.

• 🔹 Food & Beverages

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

• 🔹 Cosmetics & Personal Care

  • Products regulated under FDA Cosmetic Regulations (often referencing ASEAN Cosmetic Directive).

• 🔹 Industrial & Other Products

  • Materials requiring mandatory Myanmar Standards (MS) compliance or specific ministerial approvals.

🏭 Industries We Serve – Myanmar

GlobalCOA supports regulated industries targeting the Myanmar market, including:

• Pharmaceuticals & APIs Suppliers

• Food & Beverage Exporters/Manufacturers

• Cosmetics & Personal Care Suppliers

• Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Myanmar?

• **✔ Deep understanding of FDA Myanmar registration and quality requirements.

• ✔ COAs aligned with ASEAN/ACTD guidelines and mandatory Myanmar Standards (MS).

• ✔ Strong coordination with internationally accredited laboratories.

• ✔ Documentation suitable for FDA Registration and Import Licensing.

📝 Regulatory & Export Support – Myanmar

GlobalCOA COAs support critical processes in the Myanmar context:

• Product Registration applications to the FDA.

• Import License applications and customs clearance.

• Compliance with Myanmar Standards (MS) and technical regulations.

• Supporting documentation for GMP compliance and quality audits.

Our Myanmar-focused COAs ensure regulatory acceptance and facilitate smooth market entry.

📞 Get Started with GlobalCOA – Myanmar

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