GlobalCOA – Russia

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

Russia-Compliant COAs. EAEU-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 Russian Federation and Eurasian Economic Union (EAEU) regulatory requirements for products manufactured, imported, marketed, or exported to and from Russia.

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 across Russia and EAEU member states.

Regulatory Framework – Russia

GlobalCOA services are aligned with the requirements of:

• Ministry of Health of the Russian Federation
• Federal Service for Surveillance in Healthcare (Roszdravnadzor)
• Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” (SCEEMP)
• State Pharmacopoeia of the Russian Federation
• EAEU Technical Regulations (TR EAEU)
• Federal Agency for Technical Regulation and Metrology (Rosstandart)
• ISO / EAEU-recognized accredited testing laboratories

Our GlobalCOA Services – Russia

We provide complete lifecycle support for Certificate of Analysis documentation as per Russia and EAEU regulatory expectations:

✅ COA Preparation (Russia-Compliant)

• COA drafting as per Ministry of Health / Roszdravnadzor / SCEEMP requirements
• Alignment with Russian Pharmacopoeia, EAEU standards, and USP / BP / EP 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

• Detailed review of existing COAs for Roszdravnadzor / SCEEMP / EAEU 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 / EAEU files, and quality agreements

✅ Testing & Analytical Coordination (Russia)

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

Product Categories Covered – Russia

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 (ampoules, vials, blisters, bottles, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per EAEU technical regulations and GOST standards

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Herbal & traditional medicines
• Nutraceuticals, food ingredients, and supplements

🔹 Solvents & Processing Aids

• Residual and recovery solvents
• Cleaning and processing solvents
• Industrial and laboratory solvents

Industries We Serve – Russia

GlobalCOA supports regulated industries including:

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

Why Choose GlobalCOA for Russia?

✔ Strong expertise in Russian & EAEU regulatory systems
✔ COAs aligned with Ministry of Health, Roszdravnadzor & SCEEMP
✔ Coordination with EAEU-recognized and ISO-accredited laboratories
✔ Export-ready documentation accepted across Russia, Belarus, Kazakhstan, Armenia & Kyrgyzstan
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Russia

GlobalCOA COAs support:

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

Our Russia-focused COAs help minimize regulatory queries, testing delays, batch rejections, and shipment holds.

Get Started with GlobalCOA – Russia

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