About us
Global regulatory expertise
Vetter works with you through all phases of regulatory submission. We have an excellent track record with global regulatory agencies, including FDA, EMA, PMDA (Japan), and RP (Germany). Vetter undergoes about 10-20 inspections by different international regulatory authorities and 35-71 customer audits each year. We have successfully completed approx. 105+ FDA and EMA client products (drug products and diluents) approvals.
Inspections from 2012 to 2022
- FDA USA: 27 inspections
- Germany Regierungspräsidium Tübingen (local authority): 22 inspections
- Japan PMDA: Mutual Recognition Agreement / Paper-based inspection
- COFEPRIS Mexico: 12 inspections
- Turkey Ministry of Health: 9 inspections
- Russia Centre of Quality Control: 11 inspections
- Kazakhstan Kazakh Authority: 4 inspections
- South Korea MFDS (formerly KFDA): 6 inspections
- FDA Taiwan: 4 inspections
- EUAU: 2 inspections
- Brazil ANVISA: 3 inspections
- Health Canada: Mutual Recognition Agreement
- China NMPA: 2 inspections
- Saudi Arabia: 1 inspection
- Nigeria NAFDAC: 1 inspection
- Algeria: 1 inspection