9 successful US FDA inspections 
2013-2021
4 successful EU EMA inspections
2019-2022
30+ successful China NMPA inspections
2015-2022
4 successful Japan EMA inspections
2019-2022
4 successful South Korean MFDS inspections
2022
3 successful SwissMedic inspections 
2018-2020
300+ client audits every year
1st CDMO to support a new drug launch in China via ONE integrated CMC platform including both drug substance and drug product
105 country approvals for branded drugs
210+ CMC submission packages written to support global IND and NDA filings since 2019
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