GlobalCOA – Mongolia 🇲🇳

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

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

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

🏛️ Regulatory Framework – Mongolia

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

• Ministry of Health (MOH) / Drug and Medical Device Regulation Department: The key authority responsible for the registration and control of Drugs (Pharmaceuticals) and Medical Devices in Mongolia.

• General Agency for Specialized Inspection (GASPI) / Mongolian Agency for Standardization and Metrology (MASM):

  • MASM: The National Standards Body, responsible for developing and publishing Mongolian National Standards (MNS).

  • GASPI: The central inspection body (sometimes called the State Professional Inspection Agency or SPIA), responsible for quality and safety inspections of various regulated products, including food, and enforcing MNS and technical regulations.

• National Center for Food Safety and Quality (NCFSQ): A key body under the government responsible for food safety, often working closely with GASPI.

• National Accreditation Center (NAC): The body responsible for accrediting testing laboratories (ISO/IEC 17025, etc.).

• International Standards: Mongolian regulations often reference international standards, including:

  • BP / USP / EP / Ph. Int.: Referenced for pharmaceutical quality.

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

  • Eurasian Economic Union (EAEU) Technical Regulations (TR CU/TR EAEU): Increasingly relevant for products traded in the region.

🔬 Our GlobalCOA Services – Mongolia

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

✅ COA Preparation (Mongolia-Compliant)

• COA drafting aligned with MOH/Drug Department requirements for registration and import permits.

• Compliance with mandatory Mongolian National Standards (MNS) and technical regulations enforced by GASPI.

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

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

• COAs suitable for MOH Product Registration, GASPI import inspections, and customs documentation.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for MOH / GASPI / MNS compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory parameters (e.g., as per MNS or regulatory technical requirements).

  • Incorrect acceptance criteria or non-approved test methods.

• Harmonization with product specifications and registration dossiers submitted to the MOH/Drug Department.

✅ Testing & Analytical Coordination (Mongolia)

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

• Method selection as per:

  • Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.

  • Mongolian National Standards (MNS) 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 – Mongolia

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

  • APIs, Finished Drugs, and Excipients (regulated by MOH Drug Department).

  • Traditional Mongolian Medicines and Health Supplements.

• 🔹 Food & Beverages

  • Processed Food, Food Ingredients, and Nutritional Products (regulated by GASPI/NCFSQ).

• 🔹 Cosmetics & Personal Care

  • Products regulated under MNS and GASPI oversight.

• 🔹 Industrial Chemicals

  • Materials requiring mandatory MNS compliance or specific safety documentation.

🏭 Industries We Serve – Mongolia

GlobalCOA supports regulated industries targeting the Mongolian market, including:

• Pharmaceuticals & APIs Suppliers

• Food & Beverage Exporters/Manufacturers

• Cosmetics & Personal Care Suppliers

• Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Mongolia?

• **✔ Deep understanding of MOH Drug Regulations and mandatory GASPI/MNS Standards.

• ✔ COAs aligned with major international standards (BP/USP/Codex) as required by the authorities.

• ✔ Strong coordination with NAC-accredited and international laboratories.

• ✔ Documentation suitable for MOH Registration and GASPI Import Inspections.

📝 Regulatory & Export Support – Mongolia

GlobalCOA COAs support critical processes in the Mongolian context:

• Product Registration applications to the MOH Drug Department.

• Customs clearance and import/export documentation.

• Compliance with Mongolian National Standards (MNS) and technical regulations.

• Supporting documentation for quality assurance and GASPI inspections.

Our Mongolia-focused COAs reduce regulatory delays and ensure efficient border clearance.

📞 Get Started with GlobalCOA – Mongolia

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