Sebald Consulting

Sebald Consulting provides customized engineering services and specializes in FDA and EMA regulated companies including pharmaceutical, medical device, biotech. We work with your team to support your project objectives in a manner consistent with your company culture and fill in where necessary. Some areas of expertise include: Automation AI Project Management Computer System Validation (CSV) Software and Control System Design and Validation 21CFR11 , Annex 11 and GAMP support Establishing Calibration, Validation, or Maintenance programs Root Cause Analysis and Process Improvement Equipment commissioning and validation Process Capability Analysis