GlobalCOA – Yemen (Republic of Yemen) 🇾🇪

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

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

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

🏛️ Regulatory Framework – Yemen

The regulatory structure in Yemen, particularly for imports, is overseen by several key government bodies, often operating under complex regional conditions. COA requirements are mandatory for Customs clearance and product registration:

• Supreme Board of Drugs and Medical Appliances (SBDMA): The main regulatory authority for Pharmaceuticals (Drugs), Medical Devices, and Cosmetics under the Ministry of Public Health and Population (MoPHP). The SBDMA sets requirements for product registration, import licenses, and quality control (QC) testing.

• Yemen Standardization, Metrology and Quality Control Organization (YSMO): The national body responsible for developing and publishing Yemeni Standards (SY-SAS) and implementing quality control for Food and Industrial Products. YSMO conducts inspections of imported and locally manufactured goods to ensure compliance with standards.

• National Center for Pharmaceutical Quality Control (NCPQC): The operational arm of the SBDMA responsible for testing drug samples, both imported and locally made.

• Directorate General of Customs: Requires authenticated documentation, including the COA, for customs clearance.

• International Standards: Yemeni authorities heavily rely on international standards for quality and safety:

  • BP / USP / EP / Ph. Int.: Primary standards for pharmaceutical quality (SBDMA).

  • Codex Alimentarius / ISO Standards: Referenced for food safety and quality standards (YSMO).

🔬 Our GlobalCOA Services – Yemen

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

✅ COA Preparation (Yemen-Compliant)

• COA drafting aligned with SBDMA requirements (for Drug Registration/Import License) and mandatory YSMO/Syrian Arab Standards (often referenced) for food and industrial products.

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

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

• COAs suitable for SBDMA Product Registration, Customs clearance, and YSMO inspection, often requiring legalization/attestation.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for SBDMA / YSMO / Yemeni Standard compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., as required by SBDMA for specific drug classes or YSMO for food).

  • Incorrect acceptance criteria or non-approved test methods.

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

✅ Testing & Analytical Coordination (Yemen)

• Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally.

• Method selection as per:

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

  • Yemeni Standards / Codex Alimentarius / ISO Standards for food and other regulated products.

  • Validated in-house methods with appropriate justification.

• Support for re-testing and quality verification requested by the NCPQC or YSMO.

📦 Product Categories Covered – Yemen

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

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

  • Medical Devices (requiring QMS evidence like ISO 13485).

• 🔹 Food & Beverages

  • Processed Food, Food Ingredients, and Nutritional Products (regulated by YSMO and health authorities).

• 🔹 Cosmetics & Personal Care

  • Products regulated under SBDMA and YSMO standards.

• 🔹 Industrial & Other Products

  • Materials requiring mandatory Yemeni Standards compliance.

🏭 Industries We Serve – Yemen

GlobalCOA supports regulated industries targeting the Yemeni market, including:

• Pharmaceuticals & APIs Suppliers

• Food & Beverage Exporters/Manufacturers

• Cosmetics & Personal Care Suppliers

• Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Yemen?

• **✔ Deep understanding of SBDMA (Drugs) and YSMO (Standards) quality control mandates.

• ✔ COAs aligned with major international standards (BP/USP/Codex) required for import authorization.

• ✔ Documentation suitable for SBDMA Registration, Import Licenses, and Customs clearance.

📝 Regulatory & Export Support – Yemen

GlobalCOA COAs support critical processes in the Yemeni context:

• Product Registration applications to the SBDMA.

• Import License applications and customs clearance, often requiring legalization/attestation of commercial documents.

• Compliance with Yemeni Standards for product quality.

• Supporting documentation for GMP compliance and quality assurance.

Our Yemen-focused COAs reduce risks of non-compliance and facilitate trade into the region.

📞 Get Started with GlobalCOA – Yemen

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