GlobalCOA – Botswana 🇧🇼
Certificate of Analysis (COA) Preparation, Review & Testing Services
Botswana-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 Botswana regulatory requirements for products manufactured, marketed, or exported to or from Botswana.
We support Botswana manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Botswana Standards (BOS) and seamless acceptance in domestic and international markets.
🏛️ Regulatory Framework – Botswana
The quality and safety of products in Botswana are governed by several key authorities, with a strong emphasis on compliance with national standards and internationally recognized benchmarks. The COA is a critical supporting document for the mandatory Certificate of Conformity (CoC) and product registration:
Botswana Bureau of Standards (BOBS): The national standards body responsible for developing, promoting, and enforcing Botswana Standards (BOS). BOBS operates the Compulsory Standards Regulations (SCSR) Programme, which mandates a Certificate of Conformity (CoC) for a wide range of imported products (including Food, Chemicals, Electrical, and Mechanical products). The COA/Test Report is a key document for obtaining this CoC.
Botswana Medicines Regulatory Authority (BoMRA): The principal authority responsible for ensuring the safety, efficacy, and quality of Medicines (Human, Veterinary, Complementary), Medical Devices, and Cosmetics. BoMRA requires COAs for Product Registration Dossiers and requires the submission of samples and COAs for at least two batches of the finished drug product. COAs for raw materials are also required.
Ministry of Health & Wellness / National Food Control Board: Responsible for food safety and quality, primarily operating under the Food Control Act, 1993. BOBS sets the standards, but the Ministry enforces food safety regulations.
International Standards: Botswana actively adopts international standards (ISO, IEC, ASTM, BSI) and references major international pharmacopoeias:
BP / USP / EP / Ph. Int.: Primary standards for pharmaceutical quality.
Codex Alimentarius: Referenced for food safety and quality standards.
🔬 Our GlobalCOA Services – Botswana
We offer complete lifecycle support for Certificate of Analysis documentation as per Botswana regulatory expectations:
✅ COA Preparation (Botswana-Compliant)
COA drafting aligned with BoMRA requirements (for Drug Registration/Dossier), and mandatory BOS standards for regulated food and industrial products.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and BOS/Codex standards for general products.
COA must include detailed results against defined specifications from the relevant BOS standard or a valid international/manufacturer specification accepted by BOBS/BoMRA.
Batch-wise, stability-based, and customer-specific COAs.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for BoMRA / BOBS / BOS compliance, ensuring results meet the required technical specifications.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters (e.g., as defined in a specific BOS standard for the product category).
Incorrect acceptance criteria or non-approved test methods.
Verification for CoC Submission: Ensuring the COA/Test Report is suitable for submission to authorized Inspection & Certification Bodies (e.g., Intertek, Applus+) to obtain the mandatory Certificate of Conformity (CoC).
✅ Testing & Analytical Coordination (Botswana)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized by BOBS or international bodies, as the COA must confirm conformity to the required standard.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
Botswana Standards (BOS) or Codex Alimentarius / ISO Standards for food and other regulated products.
Validated in-house methods with appropriate justification.
Support for the required Control Testing and verification testing conducted during the CoC assessment process.
📦 Product Categories Covered – Botswana
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products
APIs, Finished Drugs, and Excipients (regulated by BoMRA).
Medical Devices and Cosmetics.
🔹 Food & Beverages
All Food Products and Ingredients (regulated by BOBS/Ministry of Health).
🔹 Industrial & Consumer Products
Goods subject to the mandatory BOBS CoC Programme (Mechanical, Electrical, Chemical, Automotive, etc.).
🏭 Industries We Serve – Botswana
GlobalCOA supports regulated industries targeting the Botswana market, including:
Pharmaceuticals & APIs Suppliers
Food & Beverage Exporters/Manufacturers
Consumer Goods Manufacturers/Importers
Trading and Export-Import businesses
🌟 Why Choose GlobalCOA for Botswana?
**✔ Deep understanding of BoMRA (Health Products) and the mandatory BOBS CoC Programme for imports.
✔ COAs specifically aligned with BOS Standards and acceptable to CoC verification agencies.
✔ Documentation suitable for Product Registration and ensuring smooth customs clearance.
📝 Regulatory & Export Support – Botswana
GlobalCOA COAs support critical processes in the Botswana context:
Product Registration Dossiers to BoMRA (requiring COAs for raw materials and finished product batches).
Submission of technical documentation to authorized inspection bodies for the mandatory Certificate of Conformity (CoC).
Customs clearance and import documentation.
Supporting documentation for quality management systems (ISO 9001) often required for the BOBS Standards Mark.
Our Botswana-focused COAs ensure compliance with stringent national standards, facilitating market entry.
📞 Get Started with GlobalCOA – Botswana
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Botswana, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.