GlobalCOA – Cuba

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

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

We support manufacturers, exporters, importers, state trading entities, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth product approval, customs clearance, and market acceptance in Cuba and international markets.

Regulatory Framework – Cuba

GlobalCOA services are aligned with the requirements of:

• Ministry of Public Health (MINSAP), Cuba
• Center for State Control of Medicines, Medical Equipment and Devices (CECMED)
• National Center for Food Safety (CNSA)
• Cuban Pharmacopoeia and officially accepted international pharmacopoeias
• National Standardization System (NC/NC ISO Standards)
• ISO / internationally accredited testing laboratories

Our GlobalCOA Services – Cuba

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

✅ COA Preparation (Cuba-Compliant)

• COA drafting as per CECMED / MINSAP requirements
• Alignment with Cuban Pharmacopoeia, and USP / BP / EP where accepted
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for state registration, import permits, customs clearance, and export documentation

✅ COA Review & Regulatory Compliance Assessment

• Expert review of existing COAs for CECMED / CNSA 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 (Cuba)

• Testing coordination through ISO-accredited / internationally recognized laboratories
• Method selection as per:
o Cuban-accepted pharmacopoeial standards
o National 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 – Cuba

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 Cuban standards

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Vaccines & biological products
• 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 – Cuba

GlobalCOA supports regulated industries including:

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

Why Choose GlobalCOA for Cuba?

✔ Strong understanding of Cuban regulatory and state registration systems
✔ COAs aligned with CECMED, MINSAP & national standards
✔ Coordination with ISO-accredited international laboratories
✔ Export-ready documentation accepted by Cuban authorities and state importers
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Cuba

GlobalCOA COAs support:

• State registration and renewals
• Import permits and customs clearance
• Export documentation
• CTD / ACTD dossier submissions
• State trading entities, importer, and customer requirements
• Regulatory inspections and quality audits

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

Get Started with GlobalCOA – Cuba

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

📩 Conta