GlobalCOA – Estonia

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

Estonia-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 Estonian and European Union regulatory requirements for products manufactured, imported, marketed, or exported to and from Estonia.

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

Regulatory Framework – Estonia

GlobalCOA services are aligned with the requirements of:

• State Agency of Medicines (SAM / Ravimiamet)
• Ministry of Social Affairs – Estonia
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• EU GMP / GDP Guidelines
• EU Food Safety Authority (EFSA) (for food & nutraceuticals)
• EU Cosmetics Regulation (EC No. 1223/2009)
• ISO / EU-GMP accredited testing laboratories

Our GlobalCOA Services – Estonia

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

✅ COA Preparation (Estonia- & EU-Compliant)

• COA drafting as per SAM (Ravimiamet) 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 release, and EU distribution

✅ COA Review & Regulatory Compliance Assessment

• Expert review of existing COAs for Estonian & 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 (Estonia / 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 – Estonia

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 – Estonia

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 Estonia?

✔ Strong expertise in Estonian & EU regulatory systems
✔ COAs aligned with SAM (Ravimiamet), 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 – Estonia

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

Get Started with GlobalCOA – Estonia

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