Validation & Qualification

• Computer System Validation
• GAMP5
• Equipment validation & qualification
• Process validation & qualification
• Equipment & Utilities

Quality Assurance

• Quality Management
• Quality Management System (QMS)

Regulatory Affairs

• RA for Medical Device​ manufacturers
• RA for Pharma and Biotech

Clinical Solutions

• CRO solutions
• Clinical Regulatory
• Medical writing
• Consultancy
• Clinical QA
• Training

Quality Control

• Chemical analysis
• Method development, validation or transfer
• Stability studies
• Microbiological analysis
• Batch release and import license

Our way of working

• Project Management & support
• Quick Scan
• Consultancy

Software

• Scilife (QMS)

Training

• Training overview
• Clinical training