GlobalCOA – Guinea (Republic of Guinea) 🇬🇳

Certificate of Analysis (COA) Preparation, Review & Testing Services

Guinea-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 Guinean regulatory requirements for products manufactured, marketed, or exported to or from Guinea.

We support Guinean manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with national standards and seamless acceptance in domestic and international markets.

🏛️ Regulatory Framework – Guinea

The regulatory system in Guinea is managed by several key authorities under the relevant ministries:

• National Directorate of Pharmacy and Medicine/Laboratory (Direction Nationale de la Pharmacie et du Médicament/Laboratoire - DNPM/DNPL): The principal authority under the Ministry of Health (Ministère de la Santé) responsible for regulating Pharmaceuticals (Drugs). The DNPL handles marketing authorization, licensing, import control, and quality control for medicines.

• National Office of Quality Control (Office Nationale de Contrôle de Qualité - ONCQ): Placed under the Ministry of Trade (Ministère du Commerce), the ONCQ is responsible for quality control of Food and Non-Food Products at the stages of production, transformation, commercialization, import, and export. The ONCQ is a key entity for COA requirements for imported and locally sold food and consumer goods.

• Guinean Institute of Normalization and Metrology (IGNM): Responsible for setting and publishing Guinean National Standards (Normes Guinéennes), which are often referenced for food and industrial products.

• National Laboratory for Quality Control of Medicines (Laboratoire National de Contrôle de Qualité des Médicaments - LNCQM): The operational unit for testing drug samples, often referencing major international pharmacopoeias.

• International Standards: Due to regional harmonization (ECOWAS/WAHO) and reliance on international trade, Guinean regulations often reference:

  • BP / USP / EP / Ph. Int.: Primary standards for pharmaceutical quality.

  • Codex Alimentarius: Referenced for food safety, quality, and labeling standards.

🔬 Our GlobalCOA Services – Guinea

We offer complete lifecycle support for Certificate of Analysis documentation as per Guinean regulatory expectations:

✅ COA Preparation (Guinea-Compliant)

• COA drafting aligned with DNPM/DNPL requirements (for Drug Registration/Import License), and ONCQ requirements for non-food and food products, including compliance with relevant Codex standards.

• Compliance with international pharmacopoeias (USP / BP / EP) for drugs.

• Batch-wise, stability-based, and customer-specific COAs.

• COAs suitable for Marketing Authorization (MA) applications and Import Control/Sampling at the port of entry (required by both DNPM and ONCQ).

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for DNPM / ONCQ / IGNM compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., as required by the ONCQ for food safety).

  • Incorrect acceptance criteria or non-approved test methods.

• Harmonization with product specifications and registration dossiers submitted to the DNPM.

✅ Testing & Analytical Coordination (Guinea)

• Testing coordination through ISO/IEC 17025 accredited laboratories recognized by Guinean authorities or by major international bodies (often required, as local accreditation capacity can be limited).

• Method selection as per:

  • Relevant Pharmacopoeial methods (BP, USP, EP) for drugs (often tested by LNCQM or approved international labs).

  • Codex Alimentarius or IGNM Standards 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 – Guinea

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

  • APIs, Finished Drugs, and Excipients (regulated by DNPM/DNPL).

  • Health Supplements.

• 🔹 Food & Beverages

  • Processed Food, Food Ingredients, and Nutritional Products (regulated by ONCQ and often referencing Codex standards).

• 🔹 Cosmetics & Personal Care

  • Products regulated under ONCQ and relevant health safety standards.

• 🔹 Industrial & Other Products

  • Non-food consumer products subject to mandatory ONCQ Quality Control.

🏭 Industries We Serve – Guinea

GlobalCOA supports regulated industries targeting the Guinean market, including:

• Pharmaceuticals & APIs Suppliers

• Food & Beverage Exporters/Manufacturers

• Cosmetics & Personal Care Suppliers

• Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Guinea?

• **✔ Deep understanding of DNPM (Drugs) and ONCQ (Food/Non-Food) quality control mandates.

• ✔ COAs aligned with major international standards (BP/USP/Codex) required for import authorization.

• ✔ Documentation suitable for Market Authorization, Import Licenses, and Customs Inspection.

📝 Regulatory & Export Support – Guinea

GlobalCOA COAs support critical processes in the Guinean context:

• Product Registration/Marketing Authorization applications to the DNPM.

• Import Authorization and customs clearance, including supporting mandatory sample testing.

• Compliance with ONCQ quality control requirements for commercialization.

• Supporting documentation for GMP compliance and quality audits.

Our Guinea-focused COAs reduce risks of non-compliance and delays during the critical import control phase.

📞 Get Started with GlobalCOA – Guinea

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