服务与解决方案

端到端 CMC 平台

临床前
临床 1 期
临床 2 期
临床 3 期
商业化
临床前
商业化
原料药

工艺研发,原料药及中间体生产

制剂

处方前,制剂及工艺开发和生产

分析

分析开发,质量控制和稳定性研究

全球申报事务药学支持

准备 CMC 文档,支持全球监管申报

满足全球质量标准

US 服务与解决方案概览

15

美国 FDA 检查

2013-2024

EURO 服务与解决方案概览

7

欧洲 EMA 检查

2009-2024

CHINA 服务与解决方案概览

53

中国 NMPA 检查

2015-2024

JAPAN 服务与解决方案概览

9

日本 PMDA 检查

2019-2024

SOUTH KOREA 服务与解决方案概览

4

南韩 MFDS 检查

2022
SWITZERLAND 服务与解决方案概览

5

瑞士 SwissMedic 检查

2018-2024

Small Molecule CDMO Pipeline

2,748

Preclinical & Phase I

326

Phase II

66

Phase III
arrow 服务与解决方案概览

61

commercial

We produced  27%  of all the small molecule drugs approved by FDA in 2023

*: Only count first approval, all of those drugs are approved by FDA, EMA, NMPA, PMDA or MFDS.

All data from last 12 month till Mar, 2024

We support 1 out of 7
global clinical programs
We produce 4 out of 10
global top-selling small molecule drugs
We produced 27% of all the small
molecule drugs approved by FDA in 2023

支持全球新药发布

1 +
支持的新药获批(自2017年)
10
个国家批准上市药品

Regulatory Dossier Preparation

supports project every milestone

Our dedicated global regulatory affairs CMC team offers CMC documentation support for IND, CTA, MAA, and NDA applications in USA, China and EU countries. There are 370+ CMC submission packages written to support global IND and NDA filings during 2019-2022.

Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossiers through forward-looking gap analysis and meticulous preparation of source documents. Our dedicated team can add tremendous value to your development programs and accelerate them to market.

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