GlobalCOA – Niger (Republic of Niger) 🇳🇪
Certificat d'Analyse (COA) Preparation, Review & Testing Services
Nigerien-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Nigerien regulatory requirements for products manufactured, marketed, or exported to or from Niger.
As a member of the West African Economic and Monetary Union (WAEMU) and ECOWAS, Niger is harmonizing its standards and quality requirements. The COA is a critical document for regulatory clearance, particularly for health products.
🏛️ Regulatory Framework – Niger
The regulatory system in Niger is primarily driven by the control of health products and the adoption of national standards, with the COA serving as the key technical evidence of quality.
Agence Nigérienne de Régulation du Secteur Pharmaceutique (ANRP) / (Nigerien Agency for the Regulation of the Pharmaceutical Sector): The main regulatory body for Pharmaceuticals (Drugs), Medical Devices, and Health Products.
Market Authorization (MA): All medicines require Marketing Authorization (MA). The COA (or Certificat d'Analyse) is a mandatory component of the technical dossier submitted for registration. The ANRP (or its predecessor, the Direction de la Pharmacie et des Laboratoires (DPHL/MT)) requires explicit, accessible criteria for the assessment of MA applications.
Quality Control: The Laboratoire National de la Santé Publique et d'Expertise (LANSPEX) is the national reference laboratory responsible for quality control testing of locally manufactured and imported products. The COA provides the specification against which LANSPEX tests the product.
Import Control: Importing medicines requires authorization. While the previous monopoly of the National Office for Pharmaceutical and Chemical Products (ONPCC) was lifted, control remains strong, and documentation like the COA is essential for clearance.
Agence Nigérienne de Normalisation, de Métrologie et de Certification (ANMC) / (Nigerien Agency for Standardization, Metrology, and Certification): The national body for standardization. The ANMC promotes and implements Nigerien Standards, which often reference international standards (like ISO and Codex Alimentarius). The ANMC facilitates conformity assessment.
Language Requirement: All regulatory documentation, including the COA, is required or strongly preferred in French (the official language) to ensure efficient regulatory processing by the ANRP and customs.
Regional Compliance: As an ECOWAS/WAEMU member, Niger adheres to regional trade and quality protocols, including the ECOWAS Common External Tariff (CET) and associated quality requirements.
🔬 Our GlobalCOA Services – Niger
We offer complete lifecycle support for Certificate of Analysis documentation, ensuring compliance with the technical, quality, and language requirements of Nigerien regulators.
✅ COA Preparation (Nigerien-Compliant)
COA drafting aligned with ANRP requirements for the MA dossier and import control.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex Alimentarius / Nigerien Standards for food and general products.
The COA must demonstrate that the product complies with the quality and safety specifications registered with the ANRP or the relevant national standard.
Documentation must be prepared in French or include verified French translations.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for ANRP / LANSPEX / ANMC compliance.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters or non-compliance with the registered specifications for pharmaceuticals.
Failure to clearly state the Batch/Lot number and Dates required for traceability and inspection.
Verification for Authorization: Ensuring the COA is robust and authentic for submission during the Marketing Authorization (MA) process for health products.
✅ Testing & Analytical Coordination (Niger)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the ANRP and LANSPEX.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
National Standards / Codex Alimentarius for food and other regulated products.
Support for the required Quality Verification Testing conducted by LANSPEX on imported consignments.
📦 Product Categories Covered – Niger
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (regulated by ANRP).
🔹 Food & Beverages: Food products and additives (subject to ANMC standards and sanitary control).
🔹 General Imports: Goods subject to ANMC's standardization and quality promotion efforts.
🌟 Why Choose GlobalCOA for Niger?
**✔ Deep understanding of ANRP's Marketing Authorization and LANSPEX's Quality Control needs.
✔ COAs aligned with Nigerien Standards and regional (ECOWAS/WAEMU) quality harmonization efforts.
✔ Documentation prepared in the required French language for official review.
📝 Regulatory & Export Support – Niger
GlobalCOA COAs support critical processes in the Nigerien context:
Product Registration Dossiers (MA) to the ANRP.
Customs clearance and import documentation, including the mandatory ECTN (Electronic Cargo Tracking Note) / BESC which requires associated shipment details.
Supporting documentation for import licenses (required for certain products like pharmaceuticals).
Our Niger-focused COAs ensure that products meet national quality benchmarks, minimizing the risk of seizure or rejection by health and customs authorities.
📞 Get Started with GlobalCOA – Niger
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Niger, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.
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