LIFE SCIENCE & HEALTH CARE CONSULTING

• Global compliance and quality management
• Development of GxP-compliant quality systems (GMP, GLP, GCP, GDP, ISO standards)
• Deviation, CAPA and change management
• Development of training systems
• Training and development of employees
• Compliance reviews and audit preparation
• Development and drafting of customized qualification and validation concepts for equipment, plants, processes and computerized systems
• Quality risk management
• Drafting of GxP documents
• Management of GxP projects
• Interdisciplinary coordination of small and large volume qualification/validation projects
• Consulting on all GxP topics
• Interim management
• Interim laboratory management
• Support of method, process and product transfers
• Performing gap analyses
• Process specialists for USP and DSP, parenteral drugs, solids, sterile filling, etc.
• Process standardization
• Development of data integrity strategies
• Due diligence