GlobalCOA – Portugal

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

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

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

Regulatory Framework – Portugal

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

• INFARMED – National Authority of Medicines and Health Products (Portugal)
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• Portuguese Ministry of Health
• EU GMP / GDP requirements
• ISO/IEC 17025–accredited testing laboratories (EU-recognized)

Our GlobalCOA Services – Portugal

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

✅ COA Preparation (Portugal & EU-Compliant)

• COA drafting as per European Pharmacopoeia (Ph. Eur.), INFARMED, 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:
– INFARMED & 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 INFARMED / 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 – Portugal / 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 – Portugal

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 – Portugal

GlobalCOA supports regulated industries across Portugal, 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 Portugal?

✔ Strong understanding of INFARMED, 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 – Portugal

GlobalCOA COAs support:

• INFARMED & 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 Portugal-focused COAs help reduce regulatory queries, prevent batch delays, and ensure uninterrupted EU market access.

Get Started with GlobalCOA – Portugal

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

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