GlobalCOA – Madagascar (Republic of Madagascar) 🇲🇬
Certificat d'Analyse (COA) Preparation, Review & Testing Services
Malagasy-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 Malagasy regulatory requirements for products manufactured, marketed, or exported to or from Madagascar.
We support Malagasy manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Malagasy Standards (Normes Malagasy - NMG) and seamless acceptance in domestic and international markets.
🏛️ Regulatory Framework – Madagascar
The regulatory system in Madagascar is structured to ensure product quality across health, food, and general consumer goods. The COA is an essential technical document for product registration and conformity assessment.
Agence du Médicament de Madagascar (AMM) / (Madagascar Drug Agency): The key regulatory authority under the Ministry of Public Health responsible for Pharmaceuticals (Drugs), APIs, and related health products. The AMM requires the COA as a mandatory part of the Marketing Authorization (MA) dossier (Pharmaceutical, Analytical, and Biological files) and often requests COAs for imported batches and samples.
Specific COA Requirement: For locally manufactured medicinal products, the Certificate(s) of batch analysis must be provided to the AMM. For imported products, COAs for both raw materials (active and inactive) and the finished product corresponding to the submitted sample batch are mandatory.
Bureau des Normes de Madagascar (BNM) / (Office of Malagasy Standards): The national body for standardization, metrology, and quality assurance. The BNM develops Malagasy Standards (NMG) and oversees product certification (e.g., the NMG Conformity Mark).
Agence de Contrôle de la Sécurité Sanitaire et de la Qualité des Denrées Alimentaires (ACSQDA): The agency responsible for the control of food safety and quality of food products (Foodstuffs). The COA is critical for demonstrating compliance with food safety regulations.
National Laboratories for Quality Control: A network of national laboratories is responsible for testing and verification, including:
Laboratoire de Chimie et de Microbiologie d'Antananarivo (LCMA): Quality control of food and agricultural goods.
Laboratory for the Control of Pesticides (LCP): Control of agro-pharmaceutical products.
Laboratoire National des Travaux Publics et du Bâtiment (LNTPB): Certification of construction materials.
Certificate of Conformity (CoC): While not explicitly a mandatory pre-shipment inspection program like in some African nations, the Certificate of Conformity (CoC) is generally required for certain high-risk and mandatory products (Pharmaceuticals, Construction Materials, etc.) to ensure compliance with Malagasy or international standards.
🔬 Our GlobalCOA Services – Madagascar
We offer complete lifecycle support for Certificate of Analysis documentation, ensuring compliance with the stringent requirements of the AMM and the technical specifications of the BNM.
✅ COA Preparation (Malagasy-Compliant)
COA drafting aligned with AMM requirements for Marketing Authorization (MA) and ACSQDA/BNM standards for food and consumer goods.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex Alimentarius / NMG standards for food and general products.
COA must include detailed testing results confirming compliance with the relevant Malagasy Standard (NMG) or the registered specifications.
COAs should be prepared in French or include verified translations to facilitate regulatory review.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for AMM / ACSQDA / BNM compliance, ensuring technical results meet the required specifications.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters (e.g., specific heavy metal or microbial limits required by a Malagasy standard).
Incorrect acceptance criteria or non-approved test methods (especially if not pharmacopoeial).
Verification for Registration/Certification: Ensuring the COA is robust enough to be accepted by the AMM for the MA dossier and for product certification by the BNM.
✅ Testing & Analytical Coordination (Madagascar)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the AMM and BNM.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
BNM Standards (NMG) / Codex Alimentarius for food and other regulated products. The LCMA uses AFNOR, ISO, and Codex standards for food.
Validated in-house methods with appropriate justification and validation reports.
Support for mandatory Batch Analysis required for pharmaceutical registration and ongoing quality control.
📦 Product Categories Covered – Madagascar
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (regulated by AMM).
🔹 Food & Beverages: All Food Products, Agricultural Goods, and Ingredients (regulated by ACSQDA/BNM).
🔹 Industrial & Consumer Products: Goods subject to mandatory BNM standards (e.g., Construction Materials, Electricals).
🏭 Industries We Serve – Madagascar
GlobalCOA supports regulated industries targeting the Malagasy market, including:
Pharmaceuticals & APIs Suppliers
Food & Beverage Exporters/Manufacturers
Trading and Export-Import businesses
🌟 Why Choose GlobalCOA for Madagascar?
**✔ Deep understanding of the AMM (Drug) and BNM (Standardization) quality control mandates.
✔ COAs specifically aligned with Malagasy Standards (NMG) and required for MA dossier submission.
✔ Documentation suitable for both Product Registration and local Quality Control Laboratory verification.
📝 Regulatory & Export Support – Madagascar
GlobalCOA COAs support critical processes in the Malagasy context:
Product Registration Dossiers (AMM) (COAs for raw materials and finished products).
Customs clearance and import documentation, where quality certificates are subject to scrutiny.
Compliance with the NMG national conformity mark for certified products.
Our Madagascar-focused COAs minimize regulatory barriers and ensure product quality is verifiable and compliant with national standards.
📞 Get Started with GlobalCOA – Madagascar
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Madagascar, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.