with vibration testing and experimental modal analysis (EMA). Support test setup, instrumentation, and data acquisition. Process...
and familiarity with FDA, EMA, and global regulations. Strong scientific writing skills and communication skills (written and verbal...
and APAC Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory...
to have (but not required): Awareness of EMA Good Pharmacovigilance Practices (GVP) Understanding of adverse events (AE) and/or AE reporting Experience...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA...