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GlobalCOA – Czech Republic

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

Czech Republic–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 coordination services in accordance with Czech Republic and European Union regulatory requirements for products manufactured in the Czech Republic or imported into / exported from the Czech Republic.

We support Czech manufacturers, EU importers, exporters, distributors, CMOs, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth approval by Czech authorities and full EU regulatory acceptance.

Regulatory Framework – Czech Republic

GlobalCOA services are aligned with the regulatory and quality requirements of:

• State Institute for Drug Control (SÚKL – Czech Republic)
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• Ministry of Health of the Czech Republic
• State Health Institute (SZÚ)
• EU GMP / GDP requirements
• ISO/IEC 17025-accredited testing laboratories (EU-recognized)

Our GlobalCOA Services – Czech Republic

We offer complete lifecycle support for Certificate of Analysis documentation as per Czech and EU regulatory expectations:

✅ COA Preparation (Czech Republic & EU-Compliant)

• COA drafting as per European Pharmacopoeia (Ph. Eur.), SÚKL, and EMA requirements
• Alignment with USP / BP / IP for non-EU imports and global exports
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– SÚKL & EMA product registrations
– EU import release & batch certification
– Export shipments
– Distributor, tender, and partner submissions

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for SÚKL / EMA / EU GMP compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or acceptance limits
– Unsupported non-pharmacopoeial test methods
• Harmonization with:
– Product specifications
– CTD / eCTD dossiers
– DMFs / ASMFs
– Manufacturing authorizations and batch documentation

✅ Testing & Analytical Coordination – Czech Republic / EU

• Testing coordination through EU-recognized ISO/IEC 17025-accredited laboratories
• Method selection based on:
– European Pharmacopoeia (Ph. Eur.)
– EMA / ICH-aligned analytical methods
– USP / BP (where accepted)
– Validated in-house methods with scientific justification
• Support for:
– Re-testing and verification
– OOS / OOT investigations
– Trend analysis and regulatory justifications

Product Categories Covered – Czech Republic

GlobalCOA provides COA services for a wide range of regulated products:

🔹 Raw Materials

• APIs and pharmaceutical actives
• Excipients
• Herbal and botanical raw materials
• Chemical intermediates

🔹 Packaging Materials

• Primary pharmaceutical packaging
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials (EU-compliant)

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Biotechnology & biologics products
• Medical and hospital-use products
• Cosmetics & personal care 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 – Czech Republic

GlobalCOA supports regulated industries across the Czech Republic, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Contract Manufacturing Organizations (CMOs)
• Cosmetics & Personal Care
• Herbal & Traditional Medicines
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals

Why Choose GlobalCOA for the Czech Republic?

✔ Strong understanding of SÚKL, EMA & EU regulatory expectations
✔ COAs aligned with European Pharmacopoeia and ICH guidelines
✔ Seamless coordination with EU-accredited laboratories
✔ EU-ready and export-ready COAs
✔ Audit-ready, inspection-friendly documentation
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Czech Republic

GlobalCOA COAs support:

• SÚKL & EMA product registrations and lifecycle variations
• EU batch release & QP-related documentation
• Import/export clearance within and outside the EU
• CTD / eCTD & ASMF submissions
• Distributor, partner, and tender requirements
• Regulatory inspections and quality audits

Our Czech Republic–focused COAs help reduce regulatory queries, prevent batch delays, and ensure uninterrupted EU market access.

Get Started with GlobalCOA – Czech Republic

Whether you require new COA preparation, review of existing COAs, or testing coordination for products manufactured in or exported from the Czech Republic, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted EU compliance partner.

📩 Contact us today to discuss your product category, Czech / EU regulatory pathway, and COA