创新药制剂CRO/CMO

新药制剂委托研发

一站式CRO与CDMO服务

• 提供新药毒理研究制剂、I~III期临床样品与商业化产品生产服务
• 美国FDA与中国NMPA双认证的GMP设施与质量系统
• 经验丰富的专业团队，擅长制定契合目标的产品开发策略与解决难溶性药物开发难题
• 提供中美欧等国家地区的IND与NDA注册资料撰写服务
• 国际接轨的设备仪器与严格的数据完整性体系，共同保障质量合规
• 具备常规及高活性口服固体生产线

“One-Stop” Drug Product Development CRO and CDMO Service

• Manufacture of Tox, Phase I-III Clinical Samples and Commercial Supply
• US FDA and NMPA Compliant Quality System and GMP Facilities
• Experienced Professional Team, Specialized in Fit-for-Purposed and/or Problem-Solving Formulation for Poorly Soluble Compounds
• INDs and NDA Documents & Dossier Preparation for China, US and Europe Regulatory Agencies
• State-of-Art Equipment and Instruments, Excellent Data Integrity System to Ensure Quality and Compliance Outcome

Separated Oral Dosage Production Line for Regular and High Potency Drug