Bioanalytical Services

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