Method DevelopmentLabor2

  • Analytical method validation (ICH Q2)
  • Analytical development of sample preparation methods
  • Troubleshooting and Robustness testing of existing LC methods
  • Isolation of impurities by using preparative chromatography
  • Drugs substances and products stress testing and/or impurity profiling (ICH Q3)
  • Development of dissolution methods
  • Analytical support for cleaning validation studies


Consulting

  • Analytical Instrument Qualification (AIQ)
  • Advanced preparation for GMP inspection/auditsChromatograph_1
  • Risk assessments
  • Laboratory instruments sales/purchase

Training

  • Training for HPLC, UPLC, and UPC technologies (theory and praxis)
  • Systematic method development strategies through modeling software (Dry
    Lab), or statistical software (Fusion)
  • Quality by Design in analytical method development and sample preparation
  • LC Troubleshooting

AuditingChromicent Berlin Detail1

  • Perform contract laboratories GMP audits in compliance with EU-GMP
    regulations