GlobalCOA – Guatemala
Certificate of Analysis (COA) Preparation, Review & Testing Services
Guatemala-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 Guatemalan regulatory requirements for products manufactured, imported, marketed, or exported to and from the Republic of Guatemala.
We support manufacturers, importers, exporters, sanitary registration holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth sanitary registration, customs clearance, and market acceptance in Guatemala and regional/international markets.
Regulatory Framework – Guatemala
GlobalCOA services are aligned with the requirements of:
• Ministry of Public Health and Social Assistance (MSPAS)
• Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA)
• Food Regulation Directorate (for food & nutraceuticals)
• Central American Technical Regulations (RTCA)
• Codex Alimentarius (for food and dietary supplements)
• Recognized international pharmacopoeias (USP / BP / EP)
• ISO / internationally accredited testing laboratories
Our GlobalCOA Services – Guatemala
We provide complete lifecycle support for Certificate of Analysis documentation as per Guatemala regulatory expectations:
✅ COA Preparation (Guatemala-Compliant)
• COA drafting as per MSPAS and RTCA requirements
• Alignment with USP / BP / EP and Codex 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 Guatemala MSPAS 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 (Guatemala)
• Testing coordination through ISO-accredited / internationally recognized laboratories
• Method selection as per:
o RTCA and Guatemala-accepted standards
o International pharmacopoeias and Codex guidelines
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 – Guatemala
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, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per RTCA / Codex norms
🔹 Finished Products
• Pharmaceutical formulations & APIs
• 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 – Guatemala
GlobalCOA supports regulated industries including:
• Pharmaceuticals & APIs
• Medical & Life Sciences Products
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Agrochemicals & Industrial Chemicals
Why Choose GlobalCOA for Guatemala?
✔ Strong understanding of Guatemala and Central American regulatory systems
✔ COAs aligned with MSPAS, RTCA & Codex standards
✔ Coordination with ISO-accredited international laboratories
✔ Export-ready documentation accepted across Guatemala, Central America & global markets
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd
Regulatory & Export Support – Guatemala
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 Guatemala-focused COAs help reduce authority queries, testing delays, batch rejections, and shipment disruptions.
Get Started with GlobalCOA – Guatemala
Whether you require new COA preparation, review of existing COAs, or testing coordination for products destined for the Republic of Guatemala, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.