GlobalCOA – Turkey (Türkiye) 🇹🇷
Certificate of Analysis (COA) Preparation, Review & Testing Services
Turkish-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 Turkish regulatory requirements for products manufactured, marketed, or exported to or from Türkiye.
We support Turkish manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Turkish Standards (TSE) and seamless acceptance in domestic and international markets, particularly for trade with the EU.
🏛️ Regulatory Framework – Turkey
GlobalCOA services are aligned with the requirements of key Turkish regulatory and standards authorities:
Turkish Medicines and Medical Devices Agency (TİTCK): The principal authority under the Ministry of Health (MOH) responsible for the regulation, inspection, and quality control of Human Medicinal Products (Drugs), Medical Devices, and Cosmetics. TİTCK approval (Licensing/Notification) and Good Manufacturing Practice (GMP) certification are mandatory for these sectors.
Turkish Standards Institution (Türk Standardları Enstitüsü - TSE): The national standards body responsible for developing and publishing Turkish Standards (TSE) and implementing mandatory and voluntary certification schemes (the TSE Mark). TSE conformity assessment is crucial for industrial and consumer goods.
Ministry of Agriculture and Forestry – General Directorate of Food and Control: Responsible for regulating Food Products, Food Ingredients, and Safety Standards (including food supplements) under relevant food laws.
Turkish Accreditation Agency (Türk Akreditasyon Kurumu - TÜRKAK): The national body for accreditation, ensuring testing laboratories, certification, and inspection bodies meet international standards (ISO/IEC 17025, etc.) and European Union (EU) notified body requirements.
EU/International Standards: Due to the Customs Union Agreement and harmonization efforts, Turkish regulations closely align with European Union directives:
European Pharmacopoeia (EP) / BP / USP: Primary standards referenced for pharmaceutical quality (TİTCK).
Codex Alimentarius / ISO 22000: Referenced for food safety and quality standards (MOAF).
ISO 22716: Referenced for Cosmetic GMP compliance (TİTCK).
🔬 Our GlobalCOA Services – Turkey
We offer complete lifecycle support for Certificate of Analysis documentation as per Turkish regulatory expectations:
✅ COA Preparation (Turkey-Compliant)
COA drafting aligned with TİTCK requirements (for Drug Licensing/Cosmetic Notification) and mandatory SASO/TSE Technical Regulations for industrial/consumer products.
Compliance with international pharmacopoeias (EP / USP / BP) for drugs and ISO/Codex standards for food/cosmetics.
Batch-wise, stability-based, and customer-specific COAs, often required in the Turkish language.
COAs suitable for TİTCK Registration Dossiers, Customs clearance, and TSE conformity assessments.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for TİTCK / TSE / MOAF compliance.
Identification and correction of non-compliance issues related to:
Missing mandatory testing parameters (e.g., as per TİTCK or MOAF regulations).
Incorrect acceptance criteria or non-approved test methods.
Compliance with the EU/CE marking requirements that are adopted by Turkey.
Harmonization with product specifications and registration dossiers submitted to the TİTCK.
✅ Testing & Analytical Coordination (Turkey)
Testing coordination through TÜRKAK-accredited (ISO/IEC 17025) or internationally recognized laboratories accepted by TİTCK and TSE.
Method selection as per:
Relevant Pharmacopoeial methods (EP, BP, USP) for medicines.
Turkish Standards (TSE) / MOAF methods 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 – Turkey
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products
APIs, Finished Drugs, and Excipients (regulated by TİTCK).
Traditional Herbal Medicinal Products and Food Supplements (regulated by TİTCK/MOAF).
🔹 Food & Beverages
Processed Food, Food Ingredients, and Nutritional Products (regulated by MOAF).
🔹 Cosmetics & Personal Care
Products regulated under TİTCK Cosmetic Regulations (aligned with EU Cosmetic Regulation).
🔹 Industrial & Consumer Products
Materials requiring mandatory TSE Certification or compliance with EU CE Marking Directives.
🏭 Industries We Serve – Turkey
GlobalCOA supports regulated industries targeting the Turkish market and those exporting from Turkey, including:
Pharmaceuticals & APIs Suppliers
Food Processing & Beverage
Cosmetics & Personal Care
Industrial Manufacturing and Trading (for TSE/CE conformity)
🌟 Why Choose GlobalCOA for Turkey?
**✔ Deep understanding of TİTCK (Health) and TSE (Standards) quality control mandates.
✔ COAs aligned with EU/CE marking requirements and major pharmacopoeias.
✔ Strong coordination with TÜRKAK-accredited laboratories.
✔ Documentation suitable for TİTCK Licensing and TSE Certification.
📝 Regulatory & Export Support – Turkey
GlobalCOA COAs support critical processes in the Turkish context:
Product Licensing/Registration applications to the TİTCK.
Customs clearance and import/export documentation, often requiring TİTCK/MOAF pre-approval.
Compliance with TSE Mandatory Standards and associated certification.
Supporting documentation for TİTCK GMP inspections and quality audits.
Our Turkey-focused COAs ensure regulatory acceptance and facilitate smooth trade within the domestic market and internationally (especially the EU).
📞 Get Started with GlobalCOA – Turkey
Whether you require new COA preparation, review of existing COAs, or testing support for Turkish manufacturing, import, or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.