GlobalCOA – China

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

China-Compliant COAs. NMPA-Ready. Import & 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 People’s Republic of China regulatory requirements for products manufactured in China or imported into / exported from China.

We support Chinese manufacturers, importers, exporters, trading companies, distributors, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth regulatory approval and seamless domestic and international market access.

Regulatory Framework – China

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

• National Medical Products Administration (NMPA)
• Center for Drug Evaluation (CDE – China)
• State Administration for Market Regulation (SAMR)
• Chinese Pharmacopoeia Commission (ChP)
• General Administration of Customs of China (GACC)
• China GMP (CFDA GMP) & PIC/S-aligned practices
• CNAS / ISO/IEC 17025–accredited testing laboratories (ILAC-recognized)

Our GlobalCOA Services – China

We provide complete lifecycle support for Certificate of Analysis documentation in line with Chinese regulatory expectations:

✅ COA Preparation (China-Compliant)

• COA drafting as per NMPA, SAMR & Chinese Pharmacopoeia (ChP) requirements
• Alignment with USP / BP / EP / IP for imported and export-oriented products
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– NMPA product registration dossiers
– Import permits & customs clearance (GACC)
– Domestic distribution & tender submissions
– Export shipments

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for NMPA / ChP / GMP compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or acceptance criteria
– Unsupported non-pharmacopoeial test methods
• Harmonization with:
– Product specifications
– CTD / China-CTD dossiers
– DMFs / ASMFs
– Import, registration, and manufacturing documentation

✅ Testing & Analytical Coordination – China

• Testing coordination through CNAS-accredited & NMPA-recognized laboratories
• Method selection based on:
– Chinese Pharmacopoeia (ChP)
– USP / BP / EP (where accepted)
– ICH-aligned analytical methods
– Validated in-house methods with scientific justification
• Support for:
– Re-testing and verification
– OOS / OOT investigations
– Trend analysis and NMPA regulatory responses

Product Categories Covered – China

GlobalCOA provides COA services across major regulated product categories:

🔹 Raw Materials

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

🔹 Packaging Materials

• Primary pharmaceutical packaging
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials (SAMR-compliant)

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Biotechnology & biologics products
• Traditional Chinese Medicines (TCM)
• 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 – China

GlobalCOA supports regulated industries across China, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Traditional Chinese Medicine (TCM) manufacturers
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Chemical & specialty materials exporters
• Trading & export-oriented companies

Why Choose GlobalCOA for China?

✔ Strong understanding of NMPA, CDE & Chinese Pharmacopoeia requirements
✔ COAs aligned with ChP, ICH & international pharmacopoeias
✔ Seamless coordination with CNAS-accredited laboratories
✔ Import-ready and export-ready COAs
✔ Audit-ready, inspection-friendly documentation
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – China

GlobalCOA COAs support:

• NMPA product registrations & variations
• Import permits & customs clearance (GACC)
• Domestic tenders & distributor requirements
• Export documentation for US, EU, UK, ASEAN & global markets
• CTD / China-CTD & DMF submissions
• Regulatory inspections and quality audits

Our China-focused COAs help reduce regulatory queries, prevent shipment delays, and ensure uninterrupted market access.

Get Started with GlobalCOA – China

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

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