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