GlobalCOA – Hungary

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

Hungary-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 Hungarian and European Union regulatory requirements for products manufactured in Hungary or imported into / exported from Hungary.

We support Hungarian manufacturers, EU importers, exporters, distributors, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth acceptance by Hungarian authorities and EU-wide regulatory compliance.

Regulatory Framework – Hungary

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

• National Institute of Pharmacy and Nutrition (OGYÉI – Hungary)
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• Hungarian Pharmacopoeia (where applicable)
• National Public Health Center (NNK)
• EU GMP / GDP requirements
• ISO/IEC 17025–accredited testing laboratories (EU-recognized)

Our GlobalCOA Services – Hungary

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

✅ COA Preparation (Hungary & EU-Compliant)

• COA drafting as per European Pharmacopoeia (Ph. Eur.), OGYÉI, and EMA requirements
• Alignment with USP / BP / IP for non-EU import and export markets
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– OGYÉI & 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 OGYÉI / 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 records

✅ Testing & Analytical Coordination – Hungary / EU

• Testing coordination through EU-recognized ISO/IEC 17025-accredited laboratories
• Method selection based on:
– European Pharmacopoeia (Ph. Eur.)
– EMA / ICH-aligned 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 – Hungary

GlobalCOA provides COA services for a broad 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
• Cosmetics & personal care products
• Herbal & traditional medicinal products
• Nutraceuticals, food ingredients, and supplements

🔹 Solvents & Processing Aids

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

Industries We Serve – Hungary

GlobalCOA supports regulated industries across Hungary, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Cosmetics & Personal Care
• Herbal & Traditional Medicines
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals
• EU export-oriented manufacturers

Why Choose GlobalCOA for Hungary?

✔ Strong understanding of OGYÉI, 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 – Hungary

GlobalCOA COAs support:

• OGYÉI & EMA product registrations and 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 Hungary-focused COAs help minimize regulatory questions, prevent batch delays, and ensure uninterrupted EU market access.

Get Started with GlobalCOA – Hungary

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

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