Bioanalytics, Residue and Environmental Analysis
Our focus is on chromatographic techniques, i.e. LC-MS/MS, GC/MS, and small molecules including peptides; but we can also provide expertise in large therapeutic protein LC-MS/MS.
We support you in:
We support you in:
- Method development and validation strategies
- Problem solving and troubleshooting
- Reduction of assay failure rate and repeats (“time is money”)
- Review, assessment and quality check of data, reports, SOPs and other documents to ensure best bioanalytical practices and regulatory compliance
- Evaluation and purchase of LC/MS instrumentation
- User requirement specifications and performance qualification tests
- Instrument evaluation in vendor`s application laboratories
- Instrument qualification and computerized system validation
Pharmaco-/Toxicokinetics (PK/TK)
- Non-compartmental PK/TK analysis with Phoenix WinNonlin 7.0, validated for GLP use
- Data interpretation and reporting
- For non-GLP and GLP studies