GlobalCOA – Germany

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

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

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

Regulatory Framework – Germany

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

• Federal Institute for Drugs and Medical Devices (BfArM)
• Paul Ehrlich Institute (PEI) (biologics & vaccines)
• Federal Office of Consumer Protection and Food Safety (BVL)
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• German Pharmacopoeia (DAB) (where applicable)
• EU GMP / GDP requirements
• ISO/IEC 17025–accredited testing laboratories (EU-recognized)

Our GlobalCOA Services – Germany

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

✅ COA Preparation (Germany & EU-Compliant)

• COA drafting as per European Pharmacopoeia (Ph. Eur.), BfArM / PEI, 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:
– BfArM / PEI & 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 BfArM / PEI / 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 – Germany / EU

• Testing coordination through EU-recognized ISO/IEC 17025-accredited laboratories
• Method selection based on:
– European Pharmacopoeia (Ph. Eur.)
– German Pharmacopoeia (DAB), where applicable
– 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 – Germany

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
• Vaccines & advanced therapies
• 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 – Germany

GlobalCOA supports regulated industries across Germany, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Vaccine & biologics manufacturing
• Contract Manufacturing Organizations (CMOs)
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals

Why Choose GlobalCOA for Germany?

✔ Strong understanding of BfArM, PEI, EMA & EU regulatory expectations
✔ COAs aligned with European & German 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 – Germany

GlobalCOA COAs support:

• BfArM / PEI & 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 Germany-focused COAs help reduce regulatory queries, prevent batch delays, and ensure uninterrupted EU and global market access.

Get Started with GlobalCOA – Germany

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

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