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Quality
successful US FDA inspections
2013-2023
successful EU EMA inspections
2019-2023
successful China NMPA inspections
2015-2024
successful Japan EMA inspection
2019-2024
successful South Korean MFDS inspections
2022
successful SwissMedic inspections
2018-2023
client audits
every year
country approvals for branded drugs
2013-2022
CMC submission packages written to support global IND and NDA filings since 2019-2022
CDMO to support a new drug launch in China via ONE integrated CMC platform including both drug substance and drug product
2015-2023