Financial and Legal Verification

• Business license and legal entity status
• Export/import registration certificates
• NMPA manufacturing license
• Environmental impact assessment approval
• Audited financials (3 years minimum)

Manufacturing Capability Assessment

• Third-party audit reports: SGS, Bureau Veritas, Intertek, TUV
• Cleanroom classification certificates (ISO Class 7 or 8)
• Production equipment inventory and age
• Capacity verification vs. claims

Quality System Verification

• Certificate validity: ISO 22716, US GMPC, ISO 13485
• Quality manual and SOP completeness
• Batch records and deviation handling
• COA turnaround time and completeness

Red Flags

• Expired certificates or scope mismatch
• Claims exceeding verified capacity
• Reluctance to provide references or tours
• Unusually low pricing (quality tradeoffs)
• No experience with your target regulatory markets

Weitai Credentials

ISO 22716:2007, US GMPC, ISO 13485, 80,000m² GMP facility, 110+ NMPA medical device registrations, 10,000+ formulation library, 80+ R&D professionals.