GlobalCOA – Senegal (Republic of Senegal) 🇸🇳

Certificat d'Analyse (COA) Preparation, Review & Testing Services

Senegalese-Compliant COAs. Regulatory-Ready. Export-Focused.

GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Senegalese regulatory requirements for products manufactured, marketed, or exported to or from Senegal.

We specialize in developing COAs that satisfy the stringent demands of the Pharmaceutical Regulatory Agency (ARP) and meet the technical requirements for imports subject to Customs verification and quality certification.

🏛️ Regulatory Framework – Senegal

Senegal's quality control system is centered on the control of health and food products, alongside general standards harmonization efforts as part of ECOWAS/WAEMU. The COA is fundamental to the two main compliance tracks:

  • Agence de Réglementation Pharmaceutique (ARP) / (Pharmaceutical Regulatory Agency): Formerly the Direction de la Pharmacie et du Médicament (DPM), the ARP (or the Ministry of Health) is the main authority for the regulation, registration, and quality control of Pharmaceuticals (Drugs), Medical Devices, and Health Products.

    • Market Authorization (MA) / Visa: All pharmaceutical products require a "Senegalese medicine visa" (MA) to be legally marketed. The COA (or Expert's Analytic Report) is a mandatory component of the technical dossier (Module 3 - Quality). The dossier must be in the CTD format and submitted in French or English (with French translation highly preferred).

    • Quality Control: The National Laboratory conducts testing for quality monitoring, product registration, and public procurement, using the submitted COA as the benchmark for quality specifications.

    • Import Control: Import Authorization is required for medicines, and a visa of the National Supply Pharmacy (PNA) is noted for these products, with the COA serving as key supporting documentation.

  • Association Sénégalaise de Normalisation (ASN) / (Senegalese Association for Standardization): The national body for standardization, quality infrastructure, and metrology. The ASN develops Senegalese Standards (NS) and manages the national quality policy, aligning standards with regional (ECOWAS) and international (ISO) norms. The ASN supports conformity assessment and certification.

  • Pre-Shipment Verification: For FOB values equal to or greater than CFAF 3,000,000 (approx. $5,000), a Certificate of Verification by an authorized inspection company (e.g., COTECNA) may be required. Although a formal PVoC program is not universally applied, a quality certificate issued by the authorities of the country of origin is a generally required document for imports and customs clearance.

  • Food and Agricultural Products: Require specialized documentation, including a sanitary certificate or animal/plant health certificate, which are forms of COA demonstrating conformity to sanitary standards (often based on Codex Alimentarius).

🔬 Our GlobalCOA Services – Senegal

We offer complete lifecycle support for Certificate of Analysis documentation, ensuring compliance with the technical, quality, and language requirements of Senegalese regulators.

✅ COA Preparation (Senegalese-Compliant)

  • COA drafting aligned with ARP requirements (CTD Module 3) for drug registration and mandatory ASN/Sanitary standards for other regulated products.

  • Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex Alimentarius / Senegalese Standards (NS) for food and general products.

  • The COA must demonstrate that the product complies with the quality and safety specifications registered with the ARP or the relevant national standard.

  • Documentation must be in French or include verified French translations.

✅ COA Review & Regulatory Compliance Assessment

  • Review of existing COAs for ARP / ASN / Customs compliance.

  • Identification and correction of non-compliance issues:

    • Missing mandatory testing parameters or non-compliance with the registered specifications for pharmaceuticals (which would result in further testing by the National Laboratory).

    • Failure to clearly state the Batch/Lot number and Dates (manufacturing/expiration) required for traceability and inspection, as detailed in labeling requirements.

  • Verification for CoV/CoC: Ensuring the COA is robust and authentic for submission during the Certificate of Verification process (if applicable) or as the general "quality certificate" required by Customs.

✅ Testing & Analytical Coordination (Senegal)

  • Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the ARP and customs inspection bodies.

  • Method selection as per:

    • Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.

    • Senegalese Standards (NS) / Codex Alimentarius for food and other regulated products.

  • Support for the required Quality Verification Testing conducted by the National Laboratory for registration and market control.

📦 Product Categories Covered – Senegal

GlobalCOA provides COA services for regulated sectors:

  • 🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (regulated by ARP).

  • 🔹 Food & Beverages: All Food Products, including milk, poultry, and meat, requiring specific Sanitary/Quality Certificates (regulated by relevant Ministries).

  • 🔹 General Imports: Goods subject to ASN's standardization and quality promotion efforts and Cotecna's verification program.

🌟 Why Choose GlobalCOA for Senegal?

  • **✔ Deep understanding of ARP's Marketing Authorization (Visa) and National Laboratory quality control needs.

  • COAs aligned with Senegalese Standards (NS) and regional (ECOWAS/WAEMU) quality harmonization efforts.

  • Documentation prepared in the required French language for official review.

📝 Regulatory & Export Support – Senegal

GlobalCOA COAs support critical processes in the Senegalese context:

  • Product Registration Dossiers (MA) to the ARP.

  • Obtaining a Certificate of Verification (if required by FOB value).

  • Customs clearance via the ASYCUDA World system, where the COA is essential for verifying classification and admissibility.

  • Supporting documentation for import authorizations for controlled goods.

Our Senegal-focused COAs ensure that products meet national quality benchmarks, minimizing the risk of administrative hold or rejection.

📞 Get Started with GlobalCOA – Senegal

Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Senegal, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.