GlobalCOA – Ukraine

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

Ukraine-Compliant COAs. EU-Aligned. 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 Ukrainian regulatory requirements and EU-harmonized standards for products manufactured, imported, marketed, or exported to and from Ukraine.

We support manufacturers, importers, exporters, MA holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth state registration, customs clearance, and market access in Ukraine and EU-aligned international markets.

Regulatory Framework – Ukraine

GlobalCOA services are aligned with the requirements of:

• Ministry of Health of Ukraine (MoH Ukraine)
• State Service of Ukraine on Medicines and Drugs Control (SMDC)
• State Expert Center of the Ministry of Health of Ukraine (SEC)
• State Pharmacopoeia of Ukraine (SPU)
• EU GMP / GDP Guidelines
• Technical Regulations of Ukraine (EU-harmonized)
• ISO / GMP-accredited testing laboratories

Our GlobalCOA Services – Ukraine

We provide complete lifecycle support for Certificate of Analysis documentation as per Ukrainian and EU-aligned regulatory expectations:

✅ COA Preparation (Ukraine-Compliant)

• COA drafting as per MoH Ukraine / SMDC / SEC requirements
• Alignment with State Pharmacopoeia of Ukraine (SPU) and European Pharmacopoeia (Ph. Eur.), plus USP / BP where applicable
• 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 Ukraine MoH / SMDC / EU-aligned compliance
• Identification and correction of:
o Missing mandatory pharmacopoeial parameters
o Incorrect specifications or acceptance criteria
o Non-validated or unsupported analytical methods
• Harmonization with CTD dossiers, registration files, DMFs/ASMFs, and quality agreements

✅ Testing & Analytical Coordination (Ukraine)

• Testing coordination through ISO / GMP-accredited and EU-recognized laboratories
• Method selection as per:
o State Pharmacopoeia of Ukraine / Ph. Eur.
o EU GMP and guideline requirements
o Validated in-house or transferred methods with justification
• Support for re-testing, OOS/OOT investigations, trend analysis, and regulatory responses

Product Categories Covered – Ukraine

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 Ukrainian & EU regulations

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Herbal & traditional medicinal 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 – Ukraine

GlobalCOA supports regulated industries including:

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

Why Choose GlobalCOA for Ukraine?

✔ Strong expertise in Ukrainian & EU-aligned regulatory systems
✔ COAs aligned with MoH Ukraine, SMDC & SPU
✔ Coordination with EU-GMP and ISO-accredited laboratories
✔ Export-ready documentation accepted across Ukraine, EU-aligned & global markets
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Ukraine

GlobalCOA COAs support:

• State registration and renewals
• Import permits and customs clearance
• Export documentation
• CTD / ASMF / DMF submissions
• Distributor, importer, and customer requirements
• Regulatory inspections and GMP audits

Our Ukraine-focused COAs help reduce authority queries, testing delays, batch rejections, and market entry risks.