• 中文 | CN

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

US Services & Solutions

15

US FDA Inspections

2013-2024

EURO Services & Solutions

7

EU EMA Inspections

2009-2024

CHINA Services & Solutions

53

China NMPA Inspections

2015-2024

JAPAN Services & Solutions

9

Japan PMDA Inspections

2019-2024

SOUTH KOREA Services & Solutions

4

South Korea MFDS Inspections

2022
SWITZERLAND Services & Solutions

5

SwissMedic Inspections

2018-2024

Small Molecule CDMO Pipeline

2,748

Preclinical & Phase I

326

Phase II

66

Phase III
arrow Services & Solutions

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

An Engine to Support Global Launch of New Drugs

1 +
New Drugs Approved since 2017
10
Country Approvals for Branded Drugs

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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