• Scientific and managerial coaching
  • Technical coaching, training and workshops
  • Quality by Design QbD
  • Analytical QbD and scientific approaches of Analytical Procedure Development and the development process toward ICH Q14
  • Method life cycle management and maintenance
  • Reviewing and writing Regulatory CMC / Module 3 documentation
  • Implementation trajectories of instrument and technique
  • Good working practices
  • Method scouting
  • Method and application development, validation and transfer
  • Troubleshooting and application improvement
  • Pragmatic quality systems, GLP, GMP