GlobalCOA – Norway

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

Norway-Compliant COAs. EEA-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 Norwegian and EEA regulatory requirements for products manufactured in Norway or imported into / exported from Norway.

We support Norwegian manufacturers, EEA importers, exporters, distributors, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth approval by Norwegian authorities and full EEA/EU market acceptance.

Regulatory Framework – Norway

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

• Norwegian Medicines Agency (Statens legemiddelverk – NoMA)
• European Medicines Agency (EMA) (via EEA alignment)
• European Pharmacopoeia (Ph. Eur.)
• Norwegian Institute of Public Health (FHI)
• Norwegian Food Safety Authority (Mattilsynet)
• EEA-aligned GMP / GDP requirements
• ISO/IEC 17025–accredited testing laboratories (EEA-recognized)

Our GlobalCOA Services – Norway

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

✅ COA Preparation (Norway & EEA-Compliant)

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

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for NoMA / EMA / EEA 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 – Norway / EEA

• Testing coordination through EEA-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 – Norway

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 (EEA-compliant)

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Biotechnology & biologics products
• Vaccines and 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 – Norway

GlobalCOA supports regulated industries across Norway, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Vaccines & biologics manufacturing
• Cosmetics & Personal Care
• Herbal & Traditional Medicines
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals

Why Choose GlobalCOA for Norway?

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

Regulatory & Export Support – Norway

GlobalCOA COAs support:

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

Our Norway-focused COAs help reduce regulatory queries, prevent batch delays, and ensure uninterrupted EEA and global market access.

Get Started with GlobalCOA – Norway

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

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