GlobalCOA – Uganda (Republic of Uganda) 🇺🇬
Certificate of Analysis (COA) Preparation, Review & Testing Services
Ugandan-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services tailored to the dual regulatory requirements of the National Drug Authority (NDA) and the Uganda National Bureau of Standards (UNBS).
The COA is a mandatory technical document required for both product registration (especially health products) and the Pre-Export Verification of Conformity (PVoC) process for most regulated imports.
🏛️ Regulatory Framework – Uganda
Uganda's import control and product quality regime is sector-specific, with the COA serving as the primary evidence of conformity for both health products and general commodities.
1. National Drug Authority (NDA)
The NDA regulates and controls the manufacture, importation, exportation, distribution, and use of Pharmaceuticals, Veterinary Products, Medical Devices, and other health-related products. The COA is mandatory at multiple stages:
Product Registration/Market Authorization: The COA is a core component of the registration dossier. The application follows the CTD (Common Technical Document) or ACTD (African CTD) format.
Required COAs: Applicants must submit the Certificate of Analysis (COA) for the Active Pharmaceutical Ingredient (API) and COAs for the Finished Pharmaceutical Product (FPP) (often for the batch used in stability studies).
Import Control: Legal provisions exist requiring authorization to import medicines, and the NDA has a functional Quality Control Laboratory (NDQCL) that samples imported products for testing against the specifications provided in the COA.
GMP Compliance: Manufacturers (both domestic and international) are required to be licensed and comply with WHO GMP guidelines, which define the necessary content and integrity of the COA.
2. Uganda National Bureau of Standards (UNBS) – PVoC
The Uganda National Bureau of Standards (UNBS) implements the mandatory Pre-Export Verification of Conformity to Standards Programme (PVoC) for most other imported regulated products (including food, cosmetics, electricals, and construction materials).
Certificate of Conformity (CoC): A mandatory Certificate of Conformity (CoC) is required for customs clearance of regulated products. This CoC is issued by a UNBS-authorized PVoC partner (e.g., SGS, Intertek, TÜV Rheinland).
Role of the COA/Test Report: The COA is the primary technical document used during the Documentary Review stage of the PVoC process. Exporters must submit a valid Test Report (COA) issued by an ISO 17025 accredited laboratory to the PVoC agent to verify the product's compliance with applicable Uganda Standards (US) or approved international standards.
Failure to obtain a CoC prior to shipment results in non-conformity and products will not be allowed to enter Uganda.
🔬 Our GlobalCOA Services – Uganda
We specialize in bridging the gap between a standard manufacturer's COA and the stringent, specific requirements of the NDA and UNBS PVoC.
✅ COA Preparation (Ugandan-Compliant)
COA drafting and formatting to meet the strict technical data and GMP requirements of the NDA dossier (CTD/ACTD format).
Test parameters and acceptance criteria are aligned with Pharmacopeial standards (for NDA) and Uganda Standards (US) for UNBS/PVoC products.
For PVoC-regulated goods, the COA is optimized for quick acceptance by the authorized PVoC partner to expedite CoC issuance.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for NDA registration compliance (correct batch details, specification alignment).
Verification that the COA is robust, traceable, and issued by a suitable ISO 17025 accredited laboratory to satisfy the UNBS PVoC requirements.
Identification of non-compliance issues that would lead to rejection during the PVoC documentary review.
✅ Testing & Analytical Coordination (Uganda)
Coordination of accredited laboratory testing to generate the comprehensive COA required for the UNBS PVoC Product Certificate and subsequent Shipment Certificate.
Method selection based on Pharmacopeial methods (BP, USP, EP) for drugs and Uganda Standards (US) / Codex Alimentarius for food and general products.
📦 Product Categories Covered – Uganda
GlobalCOA provides COA services across all regulated sectors:
🔹 NDA Regulated: Pharmaceuticals, APIs, Veterinary Drugs, Medical Devices, and Health Supplements.
🔹 UNBS PVoC Regulated: Food and Food Products, Cosmetics, Chemicals, Electricals and Electronics, Building and Construction Materials, and Automotive Products.
🌟 Why Choose GlobalCOA for Uganda?
✔ Expertise in the NDA Registration Dossier: Ensuring the COA meets the CTD/ACTD quality module requirements for market authorization.
✔ UNBS PVoC/CoC Assurance: Providing the necessary ISO 17025 accredited COAs/Test Reports to secure the mandatory Certificate of Conformity (CoC) before shipment.
✔ Dual-Agency Compliance: Covering the distinct and non-negotiable quality requirements of both the NDA and UNBS.
📝 Regulatory & Export Support – Uganda
GlobalCOA COAs are engineered to support critical import milestones:
NDA Product Registration Dossier and Import Permit application.
Obtaining the mandatory Certificate of Conformity (CoC) via the UNBS PVoC program.
Customs Clearance against the submitted CoC, which is verified by the Uganda Revenue Authority (URA).
Our Uganda-focused COAs ensure efficient regulatory passage and verifiable adherence to national safety and quality standards.
📞 Get Started with GlobalCOA – Uganda
Whether you are registering pharmaceuticals or exporting PVoC-regulated consumer goods, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner for Uganda.