Method Development
- 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
Impurity Profiling
Auditing
Perform contract laboratories GMP audits in compliance with EU-GMP regulations
Consulting
- Analytical Instrument Qualification (AIQ)
- Advanced preparation for GMP inspection/audits
- Risk assessments
- Laboratory instruments sales/purchase
Training
- Training for HPLC, UPLC, and UPC technologies (theory and praxis)
- Quality by Design in analytical method development and sample preparation
- LC Troubleshooting
