GlobalCOA – Romania

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

Romania-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 Romanian national requirements and European Union regulations for products manufactured, imported, marketed, or exported to and from Romania.

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

Regulatory Framework – Romania

GlobalCOA services are aligned with the requirements of:

• National Agency for Medicines and Medical Devices of Romania (ANMDMR)
• Ministry of Health – Romania
• European Medicines Agency (EMA)
• European Pharmacopoeia (Ph. Eur.)
• EU GMP / GDP Guidelines
• National Sanitary Veterinary and Food Safety Authority (ANSVSA) (for food & nutraceuticals)
• EU Cosmetics Regulation (EC No. 1223/2009)
• ISO / EU-GMP accredited testing laboratories

Our GlobalCOA Services – Romania

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

✅ COA Preparation (Romania- & EU-Compliant)

• COA drafting as per ANMDMR 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 Romanian & 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 (Romania / 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 – Romania

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 – Romania

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 Romania?

✔ Strong expertise in Romanian & EU regulatory systems
✔ COAs aligned with ANMDMR, 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 – Romania

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

Get Started with GlobalCOA – Romania

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