GlobalCOA – Kenya (Republic of Kenya) 🇰🇪
Certificate of Analysis (COA) Preparation, Review & Testing Services
Kenyan-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Kenyan regulatory requirements for products manufactured, marketed, or exported to or from Kenya.
The COA is a primary technical document required for both product registration (for drugs/food) and the mandatory Pre-Export Verification of Conformity (PVoC) program for general imports.
🏛️ Regulatory Framework – Kenya
Kenya's regulatory structure involves multiple powerful agencies, all requiring stringent documentation for quality and customs clearance:
Kenya Bureau of Standards (KEBS): The national standards body responsible for developing and enforcing Kenya Standards (KS). KEBS oversees the mandatory Pre-Export Verification of Conformity (PVoC) Programme for most imported products. The COA is the primary technical evidence required by the KEBS-appointed inspection agents (CABs) to issue the mandatory Certificate of Conformity (CoC).
Pharmacy and Poisons Board (PPB): The central regulatory authority for Pharmaceuticals (Drugs), Medical Devices, and Cosmetics. The PPB requires detailed COAs for:
Market Authorization (Registration) Dossiers (CTD Format): COAs for the Active Pharmaceutical Ingredient (API) and the Finished Pharmaceutical Product (FPP) batches.
Import Permits/Consignment Clearance: COAs must accompany samples and shipments for quality verification.
Kenya Revenue Authority (KRA): The customs authority. All imports must comply with KRA documentation requirements, which now include a mandatory Certificate of Origin (COO) (effective October 1, 2025). The PVoC CoC (which relies on the COA) is a key provisional document accepted for confirming origin details.
East African Community (EAC): As a member, Kenya applies harmonized regional standards for trade facilitation.
International Standards: KEBS and PPB rely on international standards:
BP / USP / EP / Ph. Int.: Primary standards for pharmaceutical quality.
Codex Alimentarius / ISO: Referenced for food and general product quality.
🔬 Our GlobalCOA Services – Kenya
We focus on supporting compliance with the two major documentation requirements: PPB registration and KEBS PVoC.
✅ COA Preparation (Kenyan-Compliant)
COA drafting aligned with PPB requirements (ICH CTD Module 3) for drug registration and mandatory KEBS/PVoC technical specifications.
Compliance with international pharmacopoeias (USP / BP / EP) for drugs and Codex/KS standards for food and general products.
COA must explicitly include the Batch Number, Manufacturing Date, and Expiry Date and confirm compliance with the relevant Kenyan Standard (KS) or approved specification.
Documentation suitable for submission to PPB's PRIMS system and for verification by the PVoC Inspection Bodies (CABs).
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for PPB / KEBS / KS compliance.
Identification and correction of non-compliance issues:
Missing mandatory testing parameters specific to the relevant KEBS standard (e.g., fortification standards for specific foods).
Incorrect acceptance criteria or non-approved test methods.
Verification for PVoC CoC: Ensuring the COA/Test Report is robust, traceable, and detailed enough to satisfy the PVoC CABs (e.g., SGS, Intertek) for the issuance of the mandatory Certificate of Conformity (CoC).
✅ Testing & Analytical Coordination (Kenya)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the PPB and KEBS PVoC agents.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
Kenya Standards (KS) / Codex Alimentarius for food and other regulated products.
Support for the required Pre-shipment testing and verification testing conducted during the PVoC process or by PPB's National Quality Control Laboratory.
📦 Product Categories Covered – Kenya
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Excipients (regulated by PPB).
🔹 Food & Beverages: All Food Products, Ingredients, and Fortified Foods (regulated by KEBS/PPB/Ministry of Health).
🔹 Industrial & Consumer Products: Goods subject to the mandatory KEBS PVoC Programme (Chemicals, Electricals, Textiles, etc.).
🌟 Why Choose GlobalCOA for Kenya?
**✔ Deep understanding of the PPB CTD format for drug quality and the KEBS PVoC (CoC) quality documentation requirements.
✔ COAs aligned with mandatory Kenya Standards (KS) and acceptable to all appointed PVoC inspection agents.
✔ Documentation suitable for both Product Registration and the critical Customs Clearance CoC.
📝 Regulatory & Export Support – Kenya
GlobalCOA COAs support critical processes in the Kenyan context:
Product Registration Dossiers to the PPB.
Submission of technical documentation (COA) to authorized PVoC inspection bodies for the mandatory Certificate of Conformity (CoC).
Customs clearance and verification (The CoC is mandatory for regulated imports).
Our Kenya-focused COAs ensure efficient regulatory passage and compliance with stringent quality verification procedures.
📞 Get Started with GlobalCOA – Kenya
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Kenya, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.