GlobalCOA – The Gambia 🇬🇲
Certificate of Analysis (COA) Preparation, Review & Testing Services
Gambian-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 Gambian regulatory requirements for products manufactured, marketed, or exported to or from The Gambia.
We support Gambian manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with national standards and rigorous pre-shipment quality mandates.
🏛️ Regulatory Framework – The Gambia
The regulatory environment in The Gambia, particularly for pharmaceuticals, has adopted stringent quality control measures, making the COA a central document in the Pre-shipment Inspection and Analysis (PSIA) process.
Medicines Control Agency (MCA): The principal regulatory authority for Pharmaceuticals (Drugs), Medical Devices, and Cosmetics. The MCA has introduced a mandatory regulation for the pre-shipment verification, inspection, quality control testing, and issuance of a Clean Report of Inspection and Analysis (CRIA) for imported pharmaceuticals, following the 2022 quality scandals.
CRIA Requirement: For specified countries (like India), the MCA mandates that all pharmaceutical shipments undergo pre-shipment document verification, physical inspection, and quality control testing by an MCA-appointed third-party agency. The COA is the primary technical document required for this CRIA process.
Food Safety and Quality Authority (FSQA): The sole National Competent Authority responsible for controlling the safety and quality of all Food (including water and beverages) and Animal Feed (Food Safety and Quality Act, 2011). COAs are essential supporting documents for food importers and exporters.
The Gambia Standards Bureau (TGSB): The national body for standardization, testing, and certification. TGSB transposes international standards (ISO, IEC, ECOWAS) and is committed to promoting product quality and consumer safety.
Registration Requirement: All medicines must be registered (authorized) by the MCA before importation is permitted. Registration dossiers (following the CTD format) must include the batch COA and samples of the product.
🔬 Our GlobalCOA Services – The Gambia
We offer complete lifecycle support for Certificate of Analysis documentation, highly focused on the mandatory MCA CRIA process:
✅ COA Preparation (Gambian-Compliant)
COA drafting aligned with MCA/FSQA requirements for Product Registration/Import and mandatory quality standards.
Compliance with international pharmacopoeias (BP / USP / EP / Ph. Int.) for drugs and Codex Alimentarius for food.
The COA for pharmaceuticals must be specific to the batch being shipped and must be uploaded during the inspection request for the Clean Report of Inspection and Analysis (CRIA).
Batch-wise, stability-based, and customer-specific COAs, ensuring all quality parameters are confirmed against specifications.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for MCA CRIA / FSQA / TGSB compliance, including verification of:
Test methods and specifications against the registered dossier.
Purity and impurity limits, especially for contaminants like Diethylene Glycol (DEG) and Ethylene Glycol (EG) in excipients/syrups.
CRIA Readiness: Ensuring the COA meets the quality standard required by the MCA-appointed third-party inspection agent (e.g., Quntrol Laboratories for India) to issue the mandatory CRIA.
✅ Testing & Analytical Coordination (The Gambia)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized by international bodies and acceptable to the MCA and FSQA.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
TGSB Standards / Codex Alimentarius for food and other regulated products.
Submission of the Method of Analysis or Standard Testing Procedure alongside the COA for verification, especially if an in-house method is used.
Support for the mandatory Pre-shipment Quality Control Testing that the COA is intended to verify.
📦 Product Categories Covered – The Gambia
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (highly regulated by MCA via the CRIA process).
🔹 Food & Beverages: All Food Products, Ingredients, and Nutritional Products (regulated by FSQA).
🔹 Cosmetics & Personal Care: Products subject to TGSB standards (e.g., GAMS ISO 22716 for GMP).
🌟 Why Choose GlobalCOA for The Gambia?
**✔ Expertise in the mandatory MCA Clean Report of Inspection and Analysis (CRIA) process for pharmaceuticals.
✔ COAs aligned with stringent international standards and MCA registration dossiers (CTD format).
✔ Documentation prepared to avoid quarantine or seizure due to quality non-conformity.
📝 Regulatory & Export Support – The Gambia
GlobalCOA COAs support critical processes in the Gambian context:
Product Registration dossiers to the MCA (COAs for three samples are required).
Mandatory CRIA application for pharmaceutical imports.
Customs clearance at Ports of Entry (the CRIA is mandatory for pharmaceutical goods).
Compliance with FSQA Import Guidelines for food and feed products.
Our Gambia-focused COAs are designed to pass the stringent pre-shipment quality verification, facilitating market access and reducing public health risk.
📞 Get Started with GlobalCOA – The Gambia
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for The Gambia, particularly for pharmaceuticals, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.