GlobalCOA β Vietnam π»π³
Certificate of Analysis (COA) Preparation, Review & Testing Services
Vietnam-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 Vietnamese regulatory requirements for products manufactured, marketed, or exported to or from Vietnam.
We support Vietnamese manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Vietnamese National Standards (TCVN) and seamless acceptance in domestic and international markets.
ποΈ Regulatory Framework β Vietnam
The regulatory system in Vietnam requires a high level of documentation, and the COA is a mandatory document for the import and registration of most regulated products:
Drug Administration of Vietnam (DAV) / Ministry of Health (MOH): The principal authority responsible for the regulation of Pharmaceuticals (Drugs). The DAV requires COAs for both drug registration dossiers (ACTD Part II - Quality Documentation) and for import license applications/first-batch quality inspection.
Vietnam Food Administration (VFA) / MOH: Responsible for the control of Food Products, Health Supplements (Functional Foods), and Food for Special Use. COAs are mandatory for the registration/declaration of conformity for high-risk foods and required as part of the documentation for import.
Directorate for Standards, Metrology and Quality (STAMEQ) / Ministry of Science and Technology (MOST): The national authority responsible for developing and implementing Vietnamese National Standards (TiΓͺu chuαΊ©n Viα»t Nam - TCVN) and technical regulations. STAMEQ's work forms the basis for quality control across all sectors.
ASEAN Harmonization: Vietnam adheres to the ASEAN Common Technical Dossier (ACTD) for pharmaceuticals and common standards for food and cosmetics.
Accreditation: COAs for imported products must be issued by a laboratory designated by the exporting country's competent authority, an independent accredited laboratory (ISO/IEC 17025), or a laboratory approved by a Vietnamese competent authority.
π¬ Our GlobalCOA Services β Vietnam
We offer complete lifecycle support for Certificate of Analysis documentation as per Vietnamese regulatory expectations:
β COA Preparation (Vietnam-Compliant)
COA drafting aligned with MOH/DAV/VFA requirements for Product Registration/Declaration and Import.
Compliance with the ACTD Part II (Quality Documentation) for pharmaceutical dossiers.
COA must include specific details (e.g., product name, batch number, analytical results vs. specifications, test methods, manufacturer/laboratory information) and often must be issued within 12 months of the date of production for food items.
Batch-wise, stability-based, and customer-specific COAs.
β COA Review & Regulatory Compliance Assessment
Review of existing COAs for DAV / VFA / TCVN / ACTD compliance, including verification of the issuing laboratory's accreditation status.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters (e.g., heavy metals for food supplements, microbial limits).
Incorrect acceptance criteria or non-approved test methods, especially those differing from the registered specification.
Harmonization with product specifications, Good Manufacturing Practice (GMP), and registration dossiers submitted to the DAV/VFA.
β Testing & Analytical Coordination (Vietnam)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) or methods recognized under the ACTD for drugs.
Vietnamese National Standards (TCVN) / VFA methods or Codex Alimentarius for food and other regulated products.
Validated in-house methods with appropriate justification.
Support for re-testing and the Quality Inspection of the first imported batch (mandatory for drugs).
π¦ Product Categories Covered β Vietnam
GlobalCOA provides COA services for regulated sectors where the document is mandatory:
πΉ Pharmaceuticals & Health Products
APIs, Finished Drugs, and Excipients (regulated by DAV/MOH).
Health Supplements/Functional Foods (high-risk food requiring Registered Declaration with VFA).
πΉ Food & Beverages
Food products, especially those under Registered Declaration (high-risk) and low-risk items under Self-Declaration.
πΉ Cosmetics & Personal Care
Products requiring COA for quality assurance supporting Cosmetic Product Notification.
πΉ Chemicals & Essential Oils
Products where COA is crucial for customs and regulatory verification of composition and purity.
π Industries We Serve β Vietnam
GlobalCOA supports regulated industries targeting the Vietnamese market, including:
Pharmaceuticals & APIs Suppliers
Food & Beverage Exporters/Manufacturers
Cosmetics & Personal Care Suppliers
Trading and Export-Import businesses
π Why Choose GlobalCOA for Vietnam?
**β Deep understanding of DAV/VFA registration and quality requirements, including ACTD structure.
β COAs aligned with mandatory TCVN and international standards.
β Strong coordination with ISO/IEC 17025 accredited laboratories accepted for import.
β Documentation suitable for Product Registration, Notification, and Import Licensing.
π Regulatory & Export Support β Vietnam
GlobalCOA COAs support critical processes in the Vietnamese context:
Product Registration dossiers to the DAV (ACTD Quality Part).
Product Declaration/Registration for Food/Health Supplements to the VFA.
Customs clearance and first-batch quality inspection for imported regulated goods.
Supporting documentation for GMP compliance and quality audits.
Our Vietnam-focused COAs reduce regulatory queries and ensure efficient handling of imports and registration processes.
π Get Started with GlobalCOA β Vietnam
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Vietnam, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.