GlobalCOA – Chile

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

Chile-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 Chilean regulatory requirements for products manufactured, imported, marketed, or exported to and from the Republic of Chile.

We support manufacturers, importers, exporters, sanitary registration holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Chilean regulations and smooth acceptance in domestic, Latin American, and international markets.

Regulatory Framework – Chile

GlobalCOA services are aligned with the requirements of:

• Instituto de Salud Pública de Chile (ISP)
• Ministry of Health (Ministerio de Salud – MINSAL)
• Chilean Pharmacopoeia (Farmacopea Chilena)
• Food and Drug Regulations of Chile
• Agencia Chilena para la Inocuidad y Calidad Alimentaria (ACHIPIA) (for food & nutraceuticals)
• Codex Alimentarius (where applicable)
• ISO / internationally accredited testing laboratories

Our GlobalCOA Services – Chile

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

✅ COA Preparation (Chile-Compliant)

• COA drafting as per ISP and MINSAL requirements
• Alignment with Chilean Pharmacopoeia, USP / BP / EP, and Codex 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

• Review of existing COAs for ISP / MINSAL 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, CTD/ACTD dossiers, DMFs, and registration documents

✅ Testing & Analytical Coordination (Chile)

• Testing through ISO-accredited / ISP-recognized laboratories
• Method selection as per:
o Chilean Pharmacopoeia / ISP-accepted methods
o National food, cosmetic, and pharmaceutical regulations
o Validated in-house methods with scientific justification
• Support for re-testing, OOS/OOT investigations, trend analysis, and regulatory responses

Product Categories Covered – Chile

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, bottles, blisters, ampoules, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per Chilean standards

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Herbal & 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 – Chile

GlobalCOA supports regulated industries in Chile including:

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

Why Choose GlobalCOA for Chile?

✔ Deep understanding of Chilean sanitary registration and ISP approval processes
✔ COAs aligned with ISP, MINSAL & Chilean Pharmacopoeia
✔ Strong coordination with ISO-accredited laboratories
✔ Export-ready documentation accepted across Chile and Latin American markets
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Chile

GlobalCOA COAs support:

• Sanitary registrations and renewals
• Import permits and customs clearance
• Export documentation
• CTD / ACTD / DMF dossier submissions
• Customer, importer, and distributor requirements
• Quality audits and regulatory inspections

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

Get Started with GlobalCOA – Chile

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