.
CDMO“一站式”解决方案
健全的供应商管理体系(GMP/EHS)
Supplier Management (GMP/EHS)
物料采购全球化
Material Availability-Supported
by Global sourcing
尊重保护知识产权
IP Respect & Protection
工艺开发最优化
Cost-effective robust
process design
质量&EHS源于设计
Quality & EHS by Design
持续创新
Innovation for
commercialization
技术沟通无障碍
Full technical understading
同一团队负责研发到生产
Lab to Plant by Same Team
持续供应能力
原料供应
Raw Material Supply
EHS
GMP
原料供应
Raw Material Supply
• 供应商资格认证:现场审计
Supplier qualification: On-site audit
• QEHS专家帮助供应商提高GMP和EHS水平
QESH expert to upgrade supplier EHS/GMP level
• 备份计划:自行生产
In-house production as backup plan
EHS
• 成熟和可操作的EHS管理体系
Fully integrated and participative
EHS management system implemented
• 通过欧美大制药公司的专项审计
Audited by US and EU big pharma customers
• 通过PSCI审计
Passed PSCI Inspection
• Eco Vadis 评级:银牌
Eco Vadis Evaluation (Score 52, silver)
• 自有的安全实验室确保工艺本质安全性
Safety Lab to ensure Risk-Free in scaling-up
GMP
• 稳健的质量体系
Robust GMP quality System
• NMPA / FDA / EDQM / WHO / PMDA / ANVISA审计通过
NMPA / FDA/EDQM / WHO / PMDA / ANVISA approval
• 供应商资格认证:现场审计
Supplier qualification: On-site audit
• QEHS专家帮助供应商提高GMP和EHS水平
QESH expert to upgrade supplier EHS/GMP level
• 备份计划:自行生产
In-house production as backup plan
• 成熟和可操作的EHS管理体系
Fully integrated and participative
EHS management system implemented
• 通过欧美大制药公司的专项审计
Audited by US and EU big pharma customers
• 通过PSCI审计
Passed PSCI Inspection
• Eco Vadis 评级:银牌
Eco Vadis Evaluation (Score 52, silver)
• 自有的安全实验室确保工艺本质安全性
Safety Lab to ensure Risk-Free in scaling-up
• 稳健的质量体系
Robust GMP quality System
• NMPA / FDA / EDQM / WHO / PMDA / ANVISA审计通过
NMPA / FDA/EDQM / WHO / PMDA / ANVISA approval