Bioanalytical
Bioanalytical method development, validation and establishment
√ LC/MS/MS bioanalytical method establishment and/or transfer for new drugs
and their metabolites or generic drug assay
√ Method validation in multiple species and various matrices according to GLP guidelines
√ Partial or cross-validation of established methods
√ Certificate of analysis (COA) as well as re-certification for test substances,
reference /metabolite standard
Pharmacokinetic sample analysis and metabolite evaluation
√ Nonclinical PK/TK/bioavailability/bioequivalence sample analysis
√ Clinical PK/bioavailability/bioequivalence sample analysis
√ LC/MS/MS sample assay of parent and key metabolites in all phases of drug
development using single or multiple analyte assay methods