GlobalCOA – South Africa

Certificate of Analysis (COA) Preparation, Review & Testing Services

South Africa–Compliant COAs. Regulatory-Ready. Import & Export-Focused.

GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing coordination services in accordance with South African regulatory requirements for products manufactured in, imported into, or exported from South Africa.

We support South African manufacturers, importers, exporters, distributors, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth regulatory approval and global market acceptance.

Regulatory Framework – South Africa

GlobalCOA services are aligned with the requirements of the following South African authorities and standards:

• South African Health Products Regulatory Authority (SAHPRA)
• South African Pharmacopoeia (SAP) and recognized international pharmacopoeias
• National Department of Health (NDoH)
• Department of Agriculture, Land Reform and Rural Development (DALRRD)
• National Regulator for Compulsory Specifications (NRCS)
• South African Bureau of Standards (SABS)
• SANAS / ISO/IEC 17025–accredited testing laboratories

Our GlobalCOA Services – South Africa

We offer complete lifecycle support for Certificate of Analysis documentation as per South African regulatory expectations:

✅ COA Preparation (South Africa–Compliant)

• COA drafting as per SAHPRA, South African Pharmacopoeia (SAP), SABS, and applicable sectoral regulations
• Alignment with USP / BP / EP / IP for imported and export-oriented products
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– SAHPRA product registration dossiers
– Import permits & customs clearance
– Export shipments
– Public tenders & distributor requirements

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for SAHPRA / NDoH / NRCS / SABS compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or acceptance limits
– Unsupported non-pharmacopoeial test methods
• Harmonization with:
– Product specifications
– CTD / ZA-CTD dossiers
– DMFs and technical files
– Import/export documentation

✅ Testing & Analytical Coordination – South Africa

• Testing coordination through SANAS-accredited and government-recognized laboratories
• Method selection based on:
– South African Pharmacopoeia (SAP)
– USP / BP / EP (SAHPRA-accepted)
– SABS / NRCS prescribed methods
– Validated in-house methods with scientific justification
• Support for:
– Re-testing and verification
– OOS / OOT investigations
– Trend analysis and regulatory explanations

Product Categories Covered – South Africa

GlobalCOA provides COA services across key regulated product categories:

🔹 Raw Materials

• APIs and pharmaceutical actives
• Excipients
• Herbal, botanical, and traditional medicine raw materials
• Chemical intermediates

🔹 Packaging Materials

• Primary pharmaceutical packaging
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials (SABS / NRCS compliant)

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Complementary & alternative medicines (CAMs)
• Nutraceuticals, food ingredients, and dietary supplements

🔹 Solvents & Processing Aids

• Residual and recovery solvents
• Cleaning and processing solvents
• Industrial and laboratory solvents

Industries We Serve – South Africa

GlobalCOA supports regulated industries across South Africa, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Complementary & Traditional Medicines
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose GlobalCOA for South Africa?

✔ Strong understanding of SAHPRA, SABS & NRCS requirements
✔ COAs aligned with South African and international pharmacopoeial standards
✔ Seamless coordination with SANAS-accredited laboratories
✔ Import-ready and export-ready COAs
✔ Audit-ready, inspection-friendly documentation
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – South Africa

GlobalCOA COAs support:

• SAHPRA product registrations & variations
• Import clearance & customs release
• Export documentation for global markets
• CTD / ZA-CTD & DMF submissions
• Distributor, importer, and tender requirements
• Quality audits and regulatory inspections

Our South Africa-focused COAs help reduce regulatory queries, prevent batch rejections, and avoid shipment delays.

Get Started with GlobalCOA – South Africa

Whether you require new COA preparation, review of existing COAs, or testing coordination for products manufactured in or exported from South Africa, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.

📩 Contact us today to discuss your product category, South African regulatory pathway, and COA requirements.