GlobalCOA – Iran 🇮🇷

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

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

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

🏛️ Regulatory Framework – Iran

GlobalCOA services are primarily aligned with the requirements of the key regulatory and standards authorities in Iran:

• Ministry of Health and Medical Education (MOHME) / Food and Drug Organization (FDO): The main regulatory body responsible for the licensing, registration, control, and supervision of Pharmaceuticals (Drugs), Food, Beverages, Cosmetics, Health Supplements, and Medical Devices. FDO approval is mandatory for production and import.

  • Iranian Pharmacopoeia: The official standard for pharmaceutical products, often referencing USP, BP, and EP.

• Institute of Standards and Industrial Research of Iran (ISIRI): The national standards body, responsible for setting and publishing mandatory Iranian National Standards (ISIRI) for thousands of industrial and consumer products.

• National Accreditation Center of Iran (NACI): The body responsible for accrediting testing, calibration, and certification bodies (ISO/IEC 17025, etc.).

• Islamic Republic of Iran Customs Administration (IRICA): Requires specific documentation, including COAs, for customs clearance of regulated goods.

🔬 Our GlobalCOA Services – Iran

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

✅ COA Preparation (Iran-Compliant)

• COA drafting aligned with FDO requirements (for registration, import/export), the Iranian Pharmacopoeia for drugs, and applicable ISIRI Standards for food, cosmetics, and industrial materials.

• Alignment with international pharmacopoeias (USP / BP / EP) and standards where required for FDO approval or export.

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

• COAs suitable for product registration (IRC - Iran Registration Code) and customs documentation.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for FDO / ISIRI / Pharmacopoeial compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory parameters as required by FDO for specific product types (e.g., microbial limits, heavy metals).

  • Incorrect acceptance criteria or non-approved test methods.

• Harmonization with product specifications, Good Manufacturing Practice (GMP), and registration dossiers.

✅ Testing & Analytical Coordination (Iran)

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

• Method selection as per:

  • Iranian Pharmacopoeia or referenced major international pharmacopoeias for drugs.

  • ISIRI Standards 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 – Iran

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

  • APIs, Finished Drugs, and Excipients (aligned with FDO/Pharmacopoeia).

  • Health Supplements and Traditional Medicines.

• 🔹 Food & Beverages

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

• 🔹 Cosmetics & Personal Care

  • Products requiring FDO approval and ISIRI standards compliance.

• 🔹 Industrial Chemicals

  • Materials requiring mandatory ISIRI Certification or specific quality documentation.

🏭 Industries We Serve – Iran

GlobalCOA supports regulated Iranian industries including:

• Pharmaceuticals & APIs

• Food & Beverage Manufacturing

• Cosmetics & Personal Care

• Chemical & Industrial Manufacturing

🌟 Why Choose GlobalCOA for Iran?

• ✔ Deep understanding of FDO and ISIRI requirements, which are key to market access in Iran.

• ✔ COAs aligned with the Iranian Pharmacopoeia and mandatory ISIRI Standards.

• ✔ Strong coordination with NACI-accredited laboratories.

• ✔ Documentation suitable for IRC (Iran Registration Code) applications and customs clearance.

📝 Regulatory & Export Support – Iran

GlobalCOA COAs support critical processes in the Iranian context:

• Product Registration (IRC) applications to the FDO.

• Import/Export Documentation and customs clearance (IRICA).

• Compliance with mandatory ISIRI standards.

• Supporting documentation for GMP compliance and quality audits.

Our Iran-focused COAs ensure regulatory acceptance and facilitate smooth trade operations.

📞 Get Started with GlobalCOA – Iran

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