GlobalCOA – Saudi Arabia 🇸🇦

GlobalCOA – Saudi Arabia 🇸🇦

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

Saudi-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 Saudi Arabian regulatory requirements for products manufactured, marketed, or exported to or from Saudi Arabia.

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

🏛️ Regulatory Framework – Saudi Arabia

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

• Saudi Food and Drug Authority (SFDA): The primary regulatory body responsible for the registration, quality, and safety control of Drugs (Pharmaceuticals), Food, Cosmetics, Medical Devices, and Feed. SFDA approval and compliance are mandatory for market access.

• Saudi Standards, Metrology and Quality Organization (SASO): The national standards body responsible for developing and publishing Saudi Standards and implementing mandatory Conformity Assessment Programs (SALEEM / SABER) for imported and locally manufactured non-food and non-drug products.

• Saudi Accreditation Center (SAC): The national accreditation body responsible for accrediting testing, calibration, and certification bodies (ISO/IEC 17025, etc.).

• General Authority for Customs (Saudi Customs): Requires specific documentation, including COAs, for customs clearance.

• International Pharmacopoeia / Standards: The SFDA and SASO often reference international standards:

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

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

  • GSO Standards: Gulf Cooperation Council Standardization Organization standards, adopted by SASO/SFDA.

🔬 Our GlobalCOA Services – Saudi Arabia

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

✅ COA Preparation (Saudi-Compliant)

• COA drafting aligned with SFDA requirements (for registration, tender, and import), SASO/SALEEM Technical Regulations, and mandatory Saudi Standards.

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

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

• COAs suitable for SFDA Product Registration, Customs clearance, and SABER/SALEEM conformity assessments.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for SFDA / SASO / GSO compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., specific contaminants or additives prohibited by SFDA/SASO).

  • Incorrect acceptance criteria or non-approved test methods.

  • Verification of conformity with the SFDA/SASO required standard (e.g., GSO standard for food items).

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

✅ Testing & Analytical Coordination (Saudi Arabia)

• Testing coordination through SAC-accredited (ISO/IEC 17025) or internationally recognized laboratories accepted by SFDA/SASO's conformity assessment bodies.

• Method selection as per:

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

  • GSO / Saudi Standards (SASO) 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 – Saudi Arabia

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

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

  • Health Supplements.

• 🔹 Food & Beverages

  • Processed Food, Food Ingredients, and Nutritional Products (regulated by SFDA and SASO/GSO).

• 🔹 Cosmetics & Personal Care

  • Products regulated under SFDA and subject to GSO Cosmetic standards.

• 🔹 Industrial & Other Products

  • Materials requiring mandatory SASO/SALEEM certification.

🏭 Industries We Serve – Saudi Arabia

GlobalCOA supports regulated industries targeting the Saudi market, including:

• Pharmaceuticals & APIs Suppliers

• Food & Beverage Exporters/Manufacturers

• Cosmetics & Personal Care Suppliers

• Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Saudi Arabia?

• **✔ Deep understanding of SFDA and mandatory SASO/SALEEM requirements.

• ✔ COAs aligned with GSO Standards and major international pharmacopoeias.

• ✔ Strong coordination with SAC-accredited and SFDA-recognized laboratories.

• ✔ Documentation suitable for SFDA Registration and SABER/SALEEM Certification.

📝 Regulatory & Export Support – Saudi Arabia

GlobalCOA COAs support critical processes in the Saudi context:

• Product Registration applications to the SFDA.

• SABER/SALEEM Certificate of Conformity (CoC) submissions (requires lab reports/COA).

• Customs clearance and import/export documentation.

• Compliance with GSO/Saudi Standards.

• Supporting documentation for GMP compliance and quality audits.

Our Saudi-focused COAs ensure regulatory acceptance and facilitate mandatory conformity assessment programs.

📞 Get Started with GlobalCOA – Saudi Arabia

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