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

Pharma & biotech

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

medical devices

  • Opportunity & Risk Analysis
  • Concept & Feasibility
  • Design & Development
  • Verification & Validation
  • Product Launch Preperation
  • Launch & Post Market

Lab 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