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
满足全球质量标准
14
美国 FDA 检查
2013-2023
6
欧洲 EMA 检查
2019-2023
50
中国 NMPA 检查
2015-2024
9
日本 PMDA 检查
2019-2024
4
南韩 MFDS 检查
4
瑞士 SwissMedic 检查
2018-2023
Small Molecule CDMO Pipeline
2,748
Preclinical & Phase I326
Phase II66
Phase III
61
commercialWe 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
Regulatory Dossier Preparation
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.
