Capabilities
BA/BE Studies to Support Development of Generic Drugs
BA/BE Studies to Support Development of Generic Drugs
- Over 150+ validated methods available as per USFDA guidelines
- Total Mass Specs: 10 [API 4000s and API 6500s]
- State-of-the-art instrumentation [with qualification]
- Analysis of drug(S) and/or metabolite(s) in biological specimen [e.g. blood, plasma, serum etc.] to support TK< PK, early phase clinical development, BA/BE and TDM studies
- Team of 40 qualified and experienced researchers with experience in method development, validation and regulated Bioanalysis for a wide range of chemically diverse drug molecules
