Services and Solutions
End-to-End CMC Platform
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
COMMERCIAL
API
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
Growing Small Molecule CRDMO Pipeline
2,403
Preclinical & Phase I
301
Phase II
59
Phase III
"D"
June 2023 vs June 2022
56
Commercial
"M"
June 2023 vs June 2022
each phase in 2023H1
16%
of global clinical stage drugs
June 30,2023
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.
