GlobalCOA – Namibia (Republic of Namibia) 🇳🇦
Certificate of Analysis (COA) Preparation, Review & Testing Services
Namibian-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Namibian regulatory requirements for products manufactured, marketed, or exported to or from Namibia.
As a member of the Southern African Customs Union (SACU), Namibia applies a common regional import regime, but specific national regulations by key bodies require the COA as a primary technical document for registration and import control.
🏛️ Regulatory Framework – Namibia
The Namibian regulatory environment is driven by health, safety, and trade standards, with the COA being central to conformity assessment and product registration:
Namibia Medicines Regulatory Council (NMRC): The key authority established under the Medicines and Related Substances Act (Act No. 13 of 2003) to regulate Medicines, Medical Devices, and related substances. The NMRC requires detailed COAs for:
Product Registration (Market Authorization): Dossiers must follow the Common Technical Document (CTD) format. The Quality Module (Module 3) requires COAs for both the Active Pharmaceutical Ingredient (API) and the Finished Pharmaceutical Product (FPP) batches.
Quality Surveillance: The NMRC's Quality Surveillance Laboratory tests samples for registration, inspection, and batch release, relying on the submitted COA for the product's quality specifications.
Namibian Standards Institution (NSI): The national body for standardization, metrology, and conformity assessment. The NSI manages the National Quality and Standards Infrastructure and provides product certification services, awarding a Certificate of Conformity and the NSI Certification Mark for products meeting Namibian and International Standards. The COA provides the technical evidence required for this certification.
Namibian Agronomic Board (NAB): Regulates the importation of Controlled Agronomic Products (grains like white maize, wheat, and pearl millet). Importers must obtain an import permit, and consignments must be accompanied by supporting documents, including a Grade Certificate (where applicable), which serves as a specialized form of COA for the quality of the product.
Namibia Revenue Authority (NamRA): The customs authority responsible for enforcing restrictions and clearances. Imports are controlled for health, safety, and technical standards, relying on permits issued by the relevant Offices of Primary Authority (OMAs), which are often contingent on quality certification (supported by the COA).
International Standards: Namibia utilizes international standards:
ICH CTD/WHO: Guiding standards for pharmaceutical quality documentation.
Codex Alimentarius/ISO: Referenced for food safety and general product standards.
🔬 Our GlobalCOA Services – Namibia
We offer complete lifecycle support for Certificate of Analysis documentation, focusing on meeting the precise technical and administrative requirements of the NMRC and NSI.
✅ COA Preparation (Namibian-Compliant)
COA drafting aligned with NMRC requirements (CTD Module 3) for medicine registration and NSI/NAB specifications for other regulated products.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex/National Standards for food and general products.
The COA must clearly state the Batch Number, Manufacturing Date, and Expiry Date and confirm compliance with the relevant Namibian Standard (NAMS) or registered specification.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for NMRC / NSI / NAB compliance.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters (e.g., specific Grade requirements for controlled agronomic products).
Discrepancies between the COA and the registered product specifications in the NMRC dossier.
Verification for Import Permit: Ensuring the COA/Test Report is suitable for the supporting documentation required by the relevant OMA (e.g., NAB) before the import permit is issued.
✅ Testing & Analytical Coordination (Namibia)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the NMRC and NSI.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
Namibian Standards (NAMS) / Codex Alimentarius for food and other regulated products.
Support for the required Batch Release Testing and quality surveillance conducted by the NMRC's Quality Surveillance Laboratory.
📦 Product Categories Covered – Namibia
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Medical Devices (regulated by NMRC).
🔹 Food & Agriculture: Controlled Agronomic Products (regulated by NAB), Fish and Fishery products (NSI provides testing services).
🔹 Industrial & Consumer Products: Goods subject to NSI's standards and certification schemes.
🌟 Why Choose GlobalCOA for Namibia?
**✔ Deep understanding of NMRC CTD format for drug quality and the NSI Product Certification process.
✔ COAs aligned with mandatory Namibian Standards (NAMS) and essential for import permits and customs clearance.
✔ Documentation suitable for both Product Registration and the critical Consignment Clearance process.
📝 Regulatory & Export Support – Namibia
GlobalCOA COAs support critical processes in the Namibian context:
Product Registration Dossiers to the NMRC (Quality Module).
Application for Import Permits from relevant OMAs (like the NAB).
Customs clearance by NamRA, which relies on the supporting permits and quality documentation.
NSI Product Certification for market access.
Our Namibia-focused COAs ensure compliance with stringent quality verification procedures, minimizing the risk of delays or rejection at the border.
📞 Get Started with GlobalCOA – Namibia
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Namibia, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.