GlobalCOA – Mali (Republic of Mali) 🇲🇱
Certificat d'Analyse (COA) Preparation, Review & Testing Services
Malian-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Malian regulatory requirements for products manufactured, marketed, or exported to or from Mali.
We support Malian manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with national standards and facilitating smooth customs and regulatory clearance.
🏛️ Regulatory Framework – Mali
Mali's regulatory system, structured under various ministries, requires robust quality documentation, particularly for health products, food, and consumer goods. The COA is a foundational technical document.
Direction Nationale de la Pharmacie et du Médicament (DNPM) / Ministry of Health: The key authority responsible for the regulation, registration, and quality control of Pharmaceuticals (Drugs), Medical Devices, and Health Products.
Marketing Authorization (MA): The DNPM requires a comprehensive dossier for product registration, and the COA is a critical part of the technical/quality file. Mali is actively engaged in ECOWAS/WAEMU regional harmonization efforts (like the AMRH initiative), which emphasizes the use of standards like the CTD format.
Import Control: DNPM is empowered to authorize the sale and control the importation of medicines. The COA is essential for the Quality Assurance Division to verify the incoming batch's compliance against the registered MA specifications.
Agence Malienne de Normalisation et de Promotion de la Qualité (AMANORM): The national body for standardization, quality promotion, and metrology. AMANORM develops and promotes Malian Standards (MN) based on international practices (ISO, ECOWAS, WAEMU). AMANORM oversees conformity assessment and promotes the National Mark of Conformity for adherence to standards.
Agence Nationale de la Sécurité Sanitaire des Aliments (ANSSA) / National Food Safety Agency: The agency responsible for ensuring the safety and quality of Food Products and Food Additives. ANSSA provides marketing authorization for food products, for which the COA is a necessary supporting document.
Laboratoire National de la Santé (LNS): The National Health Laboratory, responsible for the collection and laboratory testing of medicine samples for quality control. The COA provides the baseline specification for this verification.
International/Regional Standards: Mali adheres to regional and international standards:
BP / USP / EP / Ph. Int.: Primary standards referenced for pharmaceutical quality.
Codex Alimentarius: Referenced for food safety and quality standards.
🔬 Our GlobalCOA Services – Mali
We offer complete lifecycle support for Certificate of Analysis documentation, ensuring compliance with the technical, quality, and language requirements of Malian regulators.
✅ COA Preparation (Malian-Compliant)
COA drafting aligned with DNPM requirements (for MA dossier/Import Control) and mandatory AMANORM/ANSSA technical standards.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex/MN standards for food and general products.
The COA must demonstrate that the product complies with the relevant Malian Standard (MN) or the international standard referenced by the regulatory body.
Documentation should be prepared in French or include verified French translations for submission to the DNPM/ANSSA.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for DNPM / ANSSA / AMANORM compliance.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters as required by a specific Malian Standard or the DNPM's Quality Assurance Division.
Incorrect acceptance criteria or non-approved test methods.
Verification for Authorization: Ensuring the COA is robust and authentic for submission during the Marketing Authorization (MA) process for drugs and food products.
✅ Testing & Analytical Coordination (Mali)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the Malian authorities.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
Malian Standards (MN) / Codex Alimentarius for food and other regulated products.
Support for the required Quality Verification Testing conducted by the National Health Laboratory (LNS) on imported batches.
📦 Product Categories Covered – Mali
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (regulated by DNPM).
🔹 Food & Beverages: All Food Products, Food Additives, and Animal Feed (regulated by ANSSA).
🔹 Industrial & Consumer Products: Goods subject to AMANORM's mandatory standards.
🏭 Industries We Serve – Mali
GlobalCOA supports regulated industries targeting the Malian market, including:
Pharmaceuticals & APIs Suppliers
Food & Beverage Exporters/Manufacturers
Trading and Export-Import businesses
🌟 Why Choose GlobalCOA for Mali?
**✔ Deep understanding of DNPM's Quality Assurance Division and ANSSA's Marketing Authorization needs.
✔ COAs aligned with Malian Standards (MN) and regional (ECOWAS/WAEMU) quality harmonization efforts.
✔ Documentation prepared in the required French language for official review.
📝 Regulatory & Export Support – Mali
GlobalCOA COAs support critical processes in the Malian context:
Product Registration Dossiers (MA) to the DNPM.
Marketing Authorization for foodstuffs to the ANSSA.
Customs clearance and import documentation, including supporting material for import permits (required for certain products like vegetable and animal products).
Our Mali-focused COAs ensure that products meet national quality benchmarks, minimizing the risk of seizure or rejection at the border.
📞 Get Started with GlobalCOA – Mali
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Mali, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.