GlobalCOA – Ecuador
Certificate of Analysis (COA) Preparation, Review & Testing Services
Ecuador-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 Ecuadorian regulatory requirements for products manufactured, imported, marketed, or exported to and from the Republic of Ecuador.
We support manufacturers, importers, exporters, sanitary registration holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Ecuadorian regulations and smooth acceptance in domestic, Andean, and international markets.
Regulatory Framework – Ecuador
GlobalCOA services are aligned with the requirements of:
• National Agency for Regulation, Control and Sanitary Surveillance (ARCSA)
• Ministry of Public Health (Ministerio de Salud Pública – MSP)
• Ecuadorian Pharmacopoeia and officially recognized international pharmacopoeias
• Food Regulation Authority (for food & nutraceuticals)
• Codex Alimentarius (where applicable)
• ISO / internationally accredited testing laboratories
Our GlobalCOA Services – Ecuador
We offer complete lifecycle support for Certificate of Analysis documentation as per Ecuador regulatory expectations:
✅ COA Preparation (Ecuador-Compliant)
• COA drafting as per ARCSA and MSP requirements
• Alignment with Ecuadorian 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 ARCSA / MSP 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 (Ecuador)
• Testing through ISO-accredited / ARCSA-recognized laboratories
• Method selection as per:
o Ecuadorian Pharmacopoeia / ARCSA-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 – Ecuador
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 Ecuadorian 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 – Ecuador
GlobalCOA supports regulated industries in Ecuador including:
• Pharmaceuticals & APIs
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals
Why Choose GlobalCOA for Ecuador?
✔ Deep understanding of Ecuadorian sanitary registration and ARCSA approval processes
✔ COAs aligned with ARCSA, MSP & Ecuadorian Pharmacopoeia
✔ Strong coordination with ISO-accredited laboratories
✔ Export-ready documentation accepted across Ecuador and Andean markets
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd
Regulatory & Export Support – Ecuador
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 Ecuador-focused COAs help reduce authority queries, testing delays, batch rejections, and shipment disruptions.
Get Started with GlobalCOA – Ecuador
Whether you require new COA preparation, review of existing COAs, or testing support for products destined for the Republic of Ecuador, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.