GlobalCOA – Argentina

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

Argentina-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 services in accordance with Argentine regulatory requirements for products manufactured, imported, marketed, or exported to and from the Argentine Republic.

We support manufacturers, importers, exporters, registration holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth sanitary registration, customs clearance, and market acceptance in Argentina and MERCOSUR/international markets.

Regulatory Framework – Argentina

GlobalCOA services are aligned with the requirements of:

National Administration of Drugs, Foods and Medical Devices (ANMAT)
Ministry of Health of Argentina
National Institute of Medicines (INAME)
Argentine Pharmacopoeia (Farmacopea Argentina)
MERCOSUR Technical Regulations (GMC Resolutions)
National Food Institute (INAL) (for food & nutraceuticals)
ISO / internationally accredited testing laboratories

Our GlobalCOA Services – Argentina

We provide complete lifecycle support for Certificate of Analysis documentation as per Argentina regulatory expectations:

COA Preparation (Argentina-Compliant)

• COA drafting as per ANMAT / INAME requirements
• Alignment with Argentine Pharmacopoeia, USP / BP / EP, and MERCOSUR standards where applicable
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for sanitary registration, import permits, customs clearance, and export documentation

COA Review & Regulatory Compliance Assessment

• Expert review of existing COAs for ANMAT compliance
• Identification and correction of:
o Missing mandatory test parameters
o Incorrect specifications or acceptance criteria
o Non-pharmacopoeial or unsupported analytical methods
• Harmonization with product specifications, registration dossiers, CTD/ACTD files, and quality documentation

Testing & Analytical Coordination (Argentina)

• Testing coordination through ISO-accredited / ANMAT-recognized laboratories
• Method selection as per:
o Argentine Pharmacopoeia and MERCOSUR-accepted methods
o National and regional technical regulations
o Validated in-house methods with scientific and regulatory justification
• Support for re-testing, OOS/OOT investigations, trend analysis, and authority responses

Product Categories Covered – Argentina

GlobalCOA provides COA services for a wide range of regulated product categories:

🔹 Raw Materials

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

🔹 Packaging Materials

• Primary packaging (vials, ampoules, blisters, bottles, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per ANMAT / MERCOSUR norms

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Medical devices (COA-related components)
• Cosmetics & personal care products
• Herbal & traditional products
• Nutraceuticals, food ingredients, and dietary supplements

🔹 Solvents & Processing Aids

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

Industries We Serve – Argentina

GlobalCOA supports regulated industries including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Agrochemicals & Industrial Chemicals

Why Choose GlobalCOA for Argentina?

✔ Strong expertise in Argentina & MERCOSUR regulatory systems
✔ COAs aligned with ANMAT, INAME & national pharmacopoeial standards
✔ Coordination with ANMAT-recognized and ISO-accredited laboratories
✔ Export-ready documentation accepted across Argentina, MERCOSUR & global markets
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Argentina

GlobalCOA COAs support:

• Sanitary registrations and renewals
• Import permits and customs clearance
• Export documentation
• CTD / ACTD dossier submissions
• Distributor, importer, and customer requirements
• Regulatory inspections and quality audits

Our Argentina-focused COAs help reduce authority queries, testing delays, batch rejections, and shipment disruptions.

Get Started with GlobalCOA – Argentina

Whether you require new COA preparation, review of existing COAs, or testing coordination for products destined for the Argentine Republic, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.

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