GlobalCOA – Taiwan

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

Taiwan-Compliant COAs. TFDA-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 Republic of China (Taiwan) regulatory requirements for products manufactured in Taiwan or imported into / exported from Taiwan.

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

Regulatory Framework – Taiwan

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

• Taiwan Food and Drug Administration (TFDA)
• Ministry of Health and Welfare (MOHW), Taiwan
• Taiwan Pharmacopoeia (TP)
• Bureau of Standards, Metrology and Inspection (BSMI)
• Taiwan Customs Administration
• PIC/S-aligned GMP requirements
• ISO/IEC 17025–accredited testing laboratories (TAF / ILAC-recognized)

Our GlobalCOA Services – Taiwan

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

✅ COA Preparation (Taiwan-Compliant)

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

✅ COA Review & Regulatory Compliance Assessment

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

✅ Testing & Analytical Coordination – Taiwan

• Testing coordination through TAF-accredited & TFDA-recognized laboratories
• Method selection based on:
– Taiwan Pharmacopoeia (TP)
– 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 TFDA regulatory responses

Product Categories Covered – Taiwan

GlobalCOA provides COA services across major regulated product categories:

🔹 Raw Materials

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

🔹 Packaging Materials

• Primary pharmaceutical packaging
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials (TFDA/BSMI-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 – Taiwan

GlobalCOA supports regulated industries across Taiwan, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Traditional Chinese Medicine (TCM) manufacturers
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Chemical & specialty materials exporters
• Contract manufacturing organizations (CMOs)

Why Choose GlobalCOA for Taiwan?

✔ Strong understanding of TFDA, MOHW & Taiwan Pharmacopoeia requirements
✔ COAs aligned with TP, ICH & international pharmacopoeias
✔ Seamless coordination with TAF-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 – Taiwan

GlobalCOA COAs support:

• TFDA product registrations & variations
• Import permits & customs clearance
• Domestic tenders & distributor requirements
• Export documentation for US, EU, Japan, ASEAN & global markets
• CTD / Taiwan-CTD & DMF submissions
• Regulatory inspections and quality audits

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

Get Started with GlobalCOA – Taiwan

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

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