GlobalCOA – Sierra Leone (Republic of Sierra Leone) 🇸🇱
Certificate of Analysis (COA) Preparation, Review & Testing Services
Sierra Leonean-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Sierra Leonean regulatory requirements for products manufactured, marketed, or exported to or from Sierra Leone.
The COA is a core quality document essential for Product Registration by the Pharmacy Board and for import compliance verification by the Sierra Leone Standards Bureau (SLSB).
🏛️ Regulatory Framework – Sierra Leone
Sierra Leone's quality control is primarily driven by the health sector, with the Pharmacy Board maintaining stringent standards for regulated products. The COA is fundamental to the two main compliance tracks:
Pharmacy Board of Sierra Leone (PBSL): The key authority responsible for regulating Medicinal Products, Food/Dietary Supplements, Cosmetics, and Household Chemicals under the Pharmacy and Drugs Act 2001. The COA is mandatory for:
Product Registration/Market Authorization (MA): The COA (or Certificate of Analysis) is a critical, mandatory document for the registration dossier.
Pharmaceuticals: Applicants must submit Certificate(s) of analysis (COA) for the Active Pharmaceutical Ingredient (API) and Certificates of analysis for at least three (3) batches of the Finished Pharmaceutical Product (FPP).
Food/Supplements/Cosmetics: The Certificate of Analysis (Finished Product) is a core required document for the application checklist.
Import Control and Quality Surveillance: The PBSL conducts sampling and inspection of imported consignments at the port of entry for registered products. The COA provides the specification against which the product's quality is assessed.
Language Requirement: All documents submitted, including the COA, must be in English and legible. Reports submitted only in another language will not be accepted.
Sierra Leone Standards Bureau (SLSB): The national body for standardization, certification, and accreditation. The SLSB is responsible for ensuring the safety and quality of locally manufactured and imported products through its Import Inspection Department.
Import Inspection: The SLSB may inspect all imports at the borders, in collaboration with regulatory authorities and customs. The SLSB checks the Certificate of Conformity and labeling requirements and may perform field tests before issuing clearance. The COA is the technical document used to support the claim of conformity.
Standards Basis: The SLSB bases its standards on those of international or regional organizations, adopting the Codex Alimentarius Commission for food safety and ISO, AOAC, CEN, and ASTM standards for product test methods.
Customs Clearance: Sierra Leone utilizes the Electronic Single Window and ASYCUDA World for customs processing. While the pre-shipment inspection was replaced by destination inspection in 2009, compliance with the PBSL and SLSB requirements (supported by the COA) is mandatory for final customs release.
🔬 Our GlobalCOA Services – Sierra Leone
We offer complete lifecycle support for Certificate of Analysis documentation, focusing on meeting the precise technical and administrative requirements of the PBSL for product authorization.
✅ COA Preparation (Sierra Leonean-Compliant)
COA drafting and formatting aligned with PBSL registration guidelines for all regulated products (Pharmaceuticals, Food, Cosmetics).
Compliance with international pharmacopoeias (USP / BP / EP) for medicines and Codex Alimentarius / SLSB Standards for food and other regulated products.
The COA must clearly state the Batch Number, Manufacturing Date, and Expiry Date and confirm compliance with the relevant standard or registered specification.
Ensuring the COA is provided in the mandatory English language.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for PBSL dossier completeness (e.g., COAs for 3 FPP batches, API COA).
Identification and correction of non-compliance issues (e.g., missing analyst signature, illegible format, lack of required testing parameters).
Verification for Import Clearance: Ensuring the COA/Test Report is suitable for the SLSB's Import Inspection Department during destination inspection.
✅ Testing & Analytical Coordination (Sierra Leone)
Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the PBSL.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for medicines.
SLSB Standards / Codex Alimentarius for food and other regulated products.
Support for the required Batch Release Testing and quality verification against the specifications provided in the COA.
📦 Product Categories Covered – Sierra Leone
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products: APIs, Finished Drugs, and Medical Devices (regulated by PBSL).
🔹 Food & Beverages: Food products, Dietary Supplements, and Bottled Water (regulated by PBSL).
🔹 Cosmetics & Household Chemicals: (Regulated by PBSL).
🔹 Industrial & Consumer Products: Goods subject to SLSB's standards and import inspection.
🌟 Why Choose GlobalCOA for Sierra Leone?
**✔ Expertise in PBSL Registration Dossier requirements, especially the mandatory COAs for APIs and multiple FPP batches.
✔ COAs aligned with SLSB quality standards and suitable for the Import Inspection process.
✔ Documentation provided in the required English language for direct regulatory submission.
📝 Regulatory & Export Support – Sierra Leone
GlobalCOA COAs support critical processes in the Sierra Leonean context:
Product Registration Dossiers to the PBSL (MA issuance).
Obtaining clearance for samples sent to the PBSL for quality analysis.
Customs clearance and quality verification by the SLSB at the border.
Our Sierra Leone-focused COAs ensure products meet national quality benchmarks, preventing delays in marketing authorization and import release.
📞 Get Started with GlobalCOA – Sierra Leone
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Sierra Leone, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.