Our experience and capabilities Include:
Bioanalysis for Small Molecules:
- Successful bioanalytical method development and validation of 300 plus compounds.
- Bioanalytical services to support GLP IND enabling study package for FDA, EMEA, MHRA and other global regulatory submissions, and also for other studies requiring analytical support.
- Ability to develop and validate bioanalytical methods using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to picogram levels
- Fit-for-purpose method development for non-GLP bioanalysis
- Sample processing using precipitation, liquid-liquid extractions and solid-phase extractions
- Capability for derivatization approaches (e.g., for poorly ionizable compounds) including method development and validation
- Quantification of analyte / metabolite(s) in biological matrices such as plasma, serum and blood samples in compliance with latest regulatory requirements of USFDA, EMEA, etc.,
- Experience with developing methods for other matrices such as urine, feces, CSF, bile and various tissue homogenates
- GLP bioanalysis to support preclinical bioequivalence studies
- Experience with specialized formulations such as liposomes
- Capability for bioanalytical quantification of clinical trial samples for analyte and or metabolite(s) for Phase-I through Phase-III trials. Experience in developing bioanalytical method for specialized formulations such as liposomes, plant extracts, nutraceuticals etc.
- Equipped with Watson LIMS 21 CFR Part 11 compliant Data Management System for data
Bioanalysis for Large Molecules:
- Capability for method development and validation to comply with GLP requirements
- Validation using commercially-available ELISA kits
- Capability for peptide and protein bioanalysis by ELISA methods
- Fit-for-purpose bioanalysis for biologicals using ELISA platform
- Latest technology for micro-plate reading for ELISA assays (absorbance, fluorescence and luminescence)
- Immunogenicity/antigen-antibody assays including neutralizing antibody assays
- Capability for biomarker assays
- Biomarker identification and quantification
Elemental analysis by ICPMS