GlobalCOA – China

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

China-Compliant COAs. Regulatory-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 Chinese regulatory requirements for products manufactured in China or imported into / exported from China.

We support Chinese manufacturers, exporters, importers, trading companies, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth approval by Chinese regulators and global acceptance in export markets.

Regulatory Framework – China

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

• National Medical Products Administration (NMPA)
• Chinese Pharmacopoeia (ChP)
• State Administration for Market Regulation (SAMR)
• General Administration of Customs of China (GACC)
• National Health Commission (NHC)
• China Food and Drug Control Institute (NIFDC)
• CNAS / ISO/IEC 17025–accredited testing laboratories

Our GlobalCOA Services – China

We offer complete lifecycle support for Certificate of Analysis documentation as per Chinese regulatory expectations:

✅ COA Preparation (China-Compliant)

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

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for NMPA / SAMR / GACC compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or limits
– Non-compliant or unsupported test methods
• Harmonization with:
– Product specifications
– CTD / eCTD / China registration dossiers
– DMFs and technical files
– Import/export documentation

✅ Testing & Analytical Coordination (China)

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

Product Categories Covered – China

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

🔹 Raw Materials

• APIs and pharmaceutical actives
• Excipients
• Herbal, botanical, and traditional medicine 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
• Cosmetics & personal care products
• Traditional Chinese Medicine (TCM) 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)
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals
• Export-oriented manufacturing companies

Why Choose GlobalCOA for China?

✔ Deep understanding of NMPA, SAMR & GACC requirements
✔ COAs aligned with Chinese Pharmacopoeia and international standards
✔ Strong coordination with CNAS-accredited laboratories
✔ Import-ready and export-ready COAs
✔ Audit-ready and 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 clearance & customs release (GACC)
• Export documentation for global markets
• CTD / eCTD & DMF submissions
• Distributor, importer, and customer requirements
• Quality audits and regulatory inspections

Our China-focused COAs help minimize regulatory queries, prevent shipment delays, and ensure smooth 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 global compliance partner.

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