GlobalCOA – South Africa

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

South Africa–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 coordination services in accordance with South African regulatory requirements for products manufactured in South Africa or imported into / exported from South Africa.

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

Regulatory Framework – South Africa

GlobalCOA services are aligned with the regulatory and quality requirements of:

• South African Health Products Regulatory Authority (SAHPRA)
• Department of Health (DoH), South Africa
• South African Bureau of Standards (SABS)
• Food Safety Directorate – Department of Agriculture, Land Reform & Rural Development (DALRRD)
• National Regulator for Compulsory Specifications (NRCS)
• South African Revenue Service (SARS) – Customs
• ISO / IEC 17025–accredited testing laboratories (SANAS-accredited)

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, SABS, NRCS, and South African Medicines & Related Substances Act requirements
• Alignment with USP / BP / EP / IP where applicable for export markets
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for product registration, import permits, export documentation, and regulatory submissions

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for SAHPRA / SABS / NRCS compliance
• Identification and correction of:
o Missing mandatory test parameters
o Incorrect specifications or acceptance criteria
o Non-pharmacopoeial method justifications
• Harmonization with CTD dossiers, DMFs, product specifications, and license documents

✅ Testing & Analytical Coordination (South Africa)

• Testing through SANAS-accredited / ISO-certified laboratories
• Method selection as per:
o Recognized pharmacopoeias (BP / USP / EP)
o SABS and NRCS testing standards
o Validated in-house analytical methods with regulatory justification
• Support for re-testing, OOS / OOT investigations, and trend analysis

Product Categories Covered – South Africa

GlobalCOA provides COA services for:

🔹 Raw Materials

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

🔹 Packaging Materials

• Primary packaging (blisters, bottles, containers, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per SABS / NRCS standards

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Medical devices (where applicable)
• Cosmetics & personal care products
• Complementary & traditional medicines
• 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 including:

• Pharmaceuticals & APIs
• Medical Devices
• Cosmetics & Personal Care
• Complementary & Traditional Medicines
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose GlobalCOA for South Africa?

✔ In-depth knowledge of SAHPRA & South African regulatory frameworks
✔ COAs aligned with SABS, SAHPRA, NRCS & international pharmacopoeias
✔ Strong coordination with SANAS-accredited laboratories
✔ Export-ready documentation accepted in Africa, EU, UK, US & GCC markets
✔ Audit-ready, inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – South Africa

GlobalCOA COAs support:

• Product registration and renewals
• Import permits & customs clearance
• Export documentation
• CTD / DMF dossier submissions
• Distributor and importer requirements
• Quality audits and regulatory inspections

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

Get Started with GlobalCOA – South Africa

Whether you require new COA preparation, review of existing COAs, or testing coordination for South African manufacturing, import, or export batches, 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.