服务与解决方案概览
端到端CMC平台
临床前
临床1期
临床2期
临床3期
商业化
PRE-CLINICAL
COMMERCIAL
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
助推全球新药发布
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.
