GlobalCOA – Spain

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

Spain-Compliant COAs. EU-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 services in accordance with Spanish national requirements and European Union regulations for products manufactured, imported, marketed, or exported to and from Spain.

We support manufacturers, importers, exporters, marketing authorization holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth approval in Spain and full acceptance across the European Union and global markets.

Regulatory Framework – Spain

GlobalCOA services are aligned with the requirements of:

• Spanish Agency of Medicines and Medical Devices (AEMPS)
• Ministry of Health – Spain
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• EU GMP / GDP Guidelines
• Spanish Agency for Food Safety and Nutrition (AESAN) (for food & nutraceuticals)
• EU Cosmetics Regulation (EC No. 1223/2009)
• ISO / EU-GMP accredited testing laboratories

Our GlobalCOA Services – Spain

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

✅ COA Preparation (Spain- & EU-Compliant)

• COA drafting as per AEMPS and EMA requirements
• Alignment with European Pharmacopoeia (Ph. Eur.), and USP / BP where applicable
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for marketing authorization applications (MAA), import/export, QP batch release, and EU distribution

✅ COA Review & Regulatory Compliance Assessment

• Expert review of existing COAs for Spanish & EU regulatory compliance
• Identification and correction of:
o Missing Ph. Eur. / EU-mandatory parameters
o Incorrect specifications or acceptance limits
o Non-validated or unsupported analytical methods
• Harmonization with CTD dossiers, MA files, DMFs/ASMFs, and quality agreements

✅ Testing & Analytical Coordination (Spain / EU)

• Testing coordination through EU-GMP / ISO-accredited laboratories
• Method selection as per:
o European Pharmacopoeia (Ph. Eur.)
o EMA / EU guideline requirements
o Validated in-house or transferred analytical methods with justification
• Support for re-testing, OOS/OOT investigations, trend analysis, and regulatory responses

Product Categories Covered – Spain

GlobalCOA provides COA services for a wide range of regulated product categories:

🔹 Raw Materials

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

🔹 Packaging Materials

• Primary packaging (vials, ampoules, blisters, bottles, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per EU regulations

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Herbal & traditional medicinal 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 – Spain

GlobalCOA supports regulated industries including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Industrial & Specialty Chemicals

Why Choose GlobalCOA for Spain?

✔ Strong expertise in Spanish & EU regulatory systems
✔ COAs aligned with AEMPS, EMA & Ph. Eur.
✔ Coordination with EU-GMP and ISO-accredited laboratories
✔ Export-ready documentation accepted across EU & global markets
✔ Audit-ready and QP-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Spain

GlobalCOA COAs support:

• Marketing authorization applications & renewals
• Importation and EU distribution
• QP batch release support
• CTD / ASMF / DMF submissions
• Distributor, MA holder, and customer requirements
• Regulatory inspections and GMP audits

Our Spain-focused COAs help reduce authority questions, batch rejections, testing delays, and EU market entry risks.

Get Started with GlobalCOA – Spain

Whether you require new COA preparation, review of existing COAs, or EU-compliant testing coordination for products targeting Spain or the wider European Union, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.