Service & Solution Overview
End-to-End CMC Platform
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
COMMERCIAL
PRE-CLINICAL
COMMERCIAL
Drug Substance
Process R&D, API & Intermediates Manufacturing
Drug Product
Pre-formulation, Formulation & Process Development, Manufacturing
Analytical
Analytical Development, Quality Control, and Stability Studies
Regulatory CMC
CMC Dossier Preparation to Support Global Regulatory Filing
Meeting global quality standard
14
US FDA Inspections
2013-2023
6
EU EMA Inspections
2019-2023
50
China NMPA Inspections
2015-2024
9
Japan PMDA Inspections
2019-2024
4
South Korea MFDS Inspections
4
SwissMedic Inspections
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
An Engine to Support Global Launch of New Drugs
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.
