GlobalCOA – Sudan (Republic of Sudan) 🇸🇩
Certificate of Analysis (COA) Preparation, Review & Testing Services
Sudanese-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 Medicines and Poisons Board (NMPB) and the Sudanese Standards and Metrology Organization (SSMO).
The COA is a mandatory and highly scrutinized technical document required for both product registration and import inspection/customs clearance for all regulated goods.
🏛️ Regulatory Framework – Sudan
Sudan's regulatory framework is characterized by stringent quality control over medicines, and a mandatory pre-shipment verification for a wide range of goods to ensure conformity with national standards.
1. National Medicines and Poisons Board (NMPB)
The NMPB, under the Federal Ministry of Health, is the primary authority regulating Medicines (Pharmaceuticals), Medical Devices, and Poisons. The COA is critical in the following phases:
Product Registration/Market Authorization (MA): The COA is a mandatory and detailed component of the registration dossier (which largely follows the CTD format for quality documentation).
Required COAs: Applicants must provide:
Certificate(s) of analysis of Drug Substance(s) (API) from both the manufacturer and the supplier.
Certificate of analysis of Excipients (In-actives) from the manufacturer and supplier.
Certificate of analysis of the Finished Product (on the manufacturer's headed paper).
Batch Analysis: The dossier must include Batch Analyses for at least three (3) commercial batches of the finished product.
Import Control and Quality Surveillance: The NMPB conducts inspection and sampling of imported medicines at the port of entry for quality control testing. The COA serves as the official quality benchmark.
Specific Declarations: The COA and supporting documentation must attest to:
Freedom from Alcohol (for oral liquid dosage forms).
Freedom from TSE (Transmissible Spongiform Encephalopathy) and a Halal Certificate if the source of any substance is of animal origin.
Language Requirement: All documents, including the COA, should be in English (or Arabic).
2. Sudanese Standards and Metrology Organization (SSMO) – Verification of Conformity
The Sudanese Standards and Metrology Organization (SSMO) mandates a Verification of Conformity (VoC) program (or pre-shipment inspection/IC) for a wide range of imported products.
Inspection Certificate (IC) / Certificate of Conformity (CoC): For regulated products, an Inspection Certificate (IC) or Certificate of Conformity (CoC) is mandatory for customs clearance. This certificate is issued by an SSMO-authorized international inspection agent (e.g., CIS Commodity Inspection Services).
Role of the COA/Test Report: The COA is the primary document used during the Documentary Verification stage of the VoC process. The inspection agent assesses the COA (or valid test reports from an ISO 17025 accredited laboratory) to ensure the product's compliance with applicable Sudanese Standards or recognized international standards.
Regulated Products: Includes Food, Animal Feed, Chemical Products, Toys, Textiles, Electric and electronic products, and Construction Materials.
🔬 Our GlobalCOA Services – Sudan
We specialize in producing highly detailed COAs that meet the combined requirements of the NMPB (for health products) and the SSMO (for general imports).
✅ COA Preparation (Sudanese-Compliant)
COA drafting and formatting aligned with the specific requirements of the NMPB (headed paper, analyst signature, batch details) for registration.
Test parameters and acceptance criteria are strictly aligned with Pharmacopeial standards (for NMPB) and Sudanese Standards (or recognized international standards) for SSMO.
Ensuring inclusion of mandatory declarations (e.g., Alcohol-free, TSE-free/Halal certification).
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for NMPB dossier completeness (e.g., all 3 required FPP batch COAs, API/Excipient COAs) and administrative correctness.
Verification that the COA is robust and detailed enough to satisfy the SSMO's authorized inspection agents for the issuance of the IC/CoC.
✅ Testing & Analytical Coordination (Sudan)
Coordination of accredited laboratory testing (ISO/IEC 17025) to generate the comprehensive COA required for the SSMO VoC program.
Method selection based on Pharmacopeial methods (BP, USP, EP) for drugs and Codex Alimentarius/NIS for food and other regulated products.
📦 Product Categories Covered – Sudan
We cover the full spectrum of regulated products subject to mandatory quality verification:
🔹 NMPB Regulated: Pharmaceuticals, APIs, Medical Devices, and Poisons.
🔹 SSMO Regulated: Food, Animal Feed, Chemical Products, Toys, Textiles, Electrical/Electronic Products, and Construction Materials.
🌟 Why Choose GlobalCOA for Sudan?
✔ Expertise in the NMPB CTD Quality Module: Ensuring all mandatory COAs (API, excipient, three FPP batches) are correctly formatted and submitted.
✔ SSMO VoC/IC Compliance: Providing the necessary ISO 17025 accredited COAs/Test Reports for the Inspection Certificate (IC) issuance required for customs.
✔ Dual-Agency Focus: Covering both the stringent health regulations and the broad mandate of the national standardization body.
📝 Regulatory & Export Support – Sudan
GlobalCOA COAs are engineered to support critical import milestones:
NMPB Product Registration Dossier (MA issuance).
Obtaining the mandatory Inspection Certificate (IC) / CoC via the SSMO VoC program.
Customs Clearance against the submitted IC/CoC and relevant import permits.
Our Sudan-focused COAs ensure products meet the highest national quality standards, minimizing the risk of administrative hold or rejection.
📞 Get Started with GlobalCOA – Sudan
Whether you are registering medicines or exporting consumer goods, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner for Sudan.