GlobalCOA – Egypt (Arab Republic of Egypt) 🇪🇬
Certificate of Analysis (COA) Preparation, Review & Testing Services
Egypt-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 Egyptian regulatory requirements for products manufactured, marketed, or exported to or from Egypt.
We support Egyptian manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Egyptian Standards (ES) and seamless acceptance in domestic and international markets.
🏛️ Regulatory Framework – Egypt
The Egyptian system is highly documentation-intensive, with a multi-layered control process involving multiple agencies. The COA is a core document required for product registration, import clearance, and conformity assessment.
Egyptian Drug Authority (EDA): The principal authority responsible for the regulation, registration, and quality control of Human Pharmaceutical Products (Drugs), APIs, Medical Devices, and Cosmetics. The EDA requires detailed COAs for the Quality Module (Module 3 - ICH CTD format) of the registration dossier and for quality verification of imported batches.
National Food Safety Authority (NFSA): The key body responsible for ensuring the safety and quality of Food Products and Food Contact Materials. NFSA requires a Certificate of Inspection (CoI) for regulated food imports, and the COA/Analysis Certificate is the essential supporting document for this certification process.
Egyptian Organization for Standardization and Quality (EOS): The national body responsible for developing and issuing Egyptian Standards (ES). Compliance with mandatory ES standards is verified for both local and imported products.
General Organization for Import and Export Control (GOEIC): The agency under the Ministry of Trade and Industry responsible for physical inspection, sampling, and testing of imported non-food industrial/consumer goods at ports to ensure compliance with EOS Standards.
Advanced Cargo Information (ACI) / Nafeza System: A digital single-window customs system that requires the electronic submission of all shipment documentation, including quality certificates like the COA, 48 hours prior to shipment arrival, necessitating a high degree of document preparedness.
🔬 Our GlobalCOA Services – Egypt
We offer complete lifecycle support for Certificate of Analysis documentation as per Egyptian regulatory expectations:
✅ COA Preparation (Egypt-Compliant)
COA drafting aligned with EDA requirements (ICH CTD Module 3) for Drug Registration and NFSA/GOEIC standards for food and industrial imports.
Compliance with international pharmacopoeias (USP / BP / EP) for pharmaceuticals and Codex Alimentarius / ES for food and general products.
COA must be traceable and demonstrate compliance with the relevant Egyptian Standard (ES) or the international standard (ISO, IEC, Codex) referenced in the absence of an ES.
Documentation should be prepared with the necessary traceability (Lot/Batch Number) required for the ACI/Nafeza system.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for EDA / NFSA / EOS compliance, ensuring results meet the legally binding specifications.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters (e.g., Aflatoxin test for grains, dioxin analysis for dairy, heavy metals).
Incorrect acceptance criteria or non-approved test methods.
Verification for CoI/GOEIC: Ensuring the COA/Test Report is suitable for submission to authorized Conformity Assessment Bodies (CABs, e.g., Intertek, SGS) to obtain the mandatory Certificate of Inspection (CoI) for food or for direct submission to GOEIC for industrial products.
✅ Testing & Analytical Coordination (Egypt)
Testing coordination through EGAC-accredited (ISO/IEC 17025) or internationally recognized laboratories accepted by the EDA, NFSA, and GOEIC.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
Egyptian Standards (ES) / Codex Alimentarius for food and other regulated products.
Validated in-house methods with appropriate justification.
Support for the required Quality Verification Testing conducted by EDA's laboratories or the GOEIC/NFSA laboratories upon arrival at Egyptian ports.
📦 Product Categories Covered – Egypt
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products
APIs, Finished Drugs, and Excipients (regulated by EDA).
🔹 Food & Beverages
All Food Products, Ingredients, and Nutritional Products (regulated by NFSA).
🔹 Industrial & Consumer Products
Goods subject to mandatory GOEIC Inspection and EOS Standards.
🏭 Industries We Serve – Egypt
GlobalCOA supports all regulated industries targeting the Egyptian market, including:
Pharmaceuticals & APIs Suppliers
Food & Beverage Exporters/Manufacturers
Consumer Goods Trading and Export-Import businesses
🌟 Why Choose GlobalCOA for Egypt?
**✔ Deep understanding of the EDA (Drug), NFSA (Food), and GOEIC (Industrial) quality control mandates.
✔ COAs aligned with Egyptian Standards (ES) and the digital requirements of the ACI/Nafeza system.
✔ Documentation suitable for both Product Registration and the mandatory Certificate of Inspection (CoI) for customs clearance.
📝 Regulatory & Export Support – Egypt
GlobalCOA COAs support critical processes in the Egyptian context:
Product Registration Dossiers to the EDA (Quality Module 3).
Electronic submission of quality documents into the ACI/Nafeza customs system.
Obtaining the mandatory Certificate of Inspection (CoI) from NFSA CABs for food imports.
Customs clearance and import documentation.
Our Egypt-focused COAs ensure compliance with stringent quality verification procedures, reducing delays at Egyptian ports.
📞 Get Started with GlobalCOA – Egypt
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Egypt, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.