Greater Munich Metropolitan Area
• quality control • bioassays • adventitious agents testing • PCR • biochemical analytics, in-process-control and production analytics for biologics • commercial production and phase 3 clinical supply • development and validation of analytical methods • automation of analytical methods and sample preparation • method transfers • testing and release of reagents and raw materials • generation of dossiers for health authorities (EMA, FDA, PEI) • participation in health authority meetings • preparation of inspections, inspection support, audits • handling of investigations, CAPAs, troubleshooting activities • establishment of electronic-record-systems • analytics, registration projects for phase 3 and marked products • analytics, process transfers for phase 3 and marked products • analytics, startup projects for biologics production facilities