Project Management

• Technology Transfer
• New product introductions
• Process development and support
• Packaging and serialisation

Validation & Qualification

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

Regulatory Affairs

• Regulatory strategy plan
• Medical and scientific writing
• Global submissions
• Post Market regulatory

Quality Control

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

Clinical Solutions

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

Quality Assurance

• Quality Assurance
• Quality Management Systems
• Continuous Improvement

Software

• QualityKick

Training

• Training overview
• Clinical training offerings

Our way of working

• Consultancy
• Projects
• Quick Scan
• Auditor
• Academy model