These studies require:

• Highly selective chromatographic methods
• Robust extraction procedures to maintain recovery Analytes and metabolites
• Stability controlled sample preparation
• Sensitive and specific mass transitions for each Analyte/metabolites
• Rigorous validation as per global regulatory expectations (EMA, FDA, ANVISA, WHO, Canada)
• Our ability to perform such specialized assays highlights our analytical maturity and proficiency in supporting complex BA/BE and clinical programs.

Our team excels in addressing complex challenges such as:

• Development of robust chiral chromatographic methods
• Separation of closely related isomers with minimal interference
• Accurate quantification of each enantiomer under stringent sensitivity requirements
• Ensuring stability and reproducibility across long analytical runs
• Compliance with global regulatory expectations for chiral drugs
• Managing shifts in enantiomer interconversion or degradation

This expertise ensures that sponsors receive high quality, defensible data for regulatory filings in global markets.

• Deep expertise in multi analyte and multi metabolite quantification
• Proven success across the most challenging therapeutic classes
• Large scientific team with decades of method development experience
• High throughput operations that safeguard project timelines
• Reliable, reproducible data that withstand global regulatory scrutiny
• Your Trusted Partner for Complex Bioanalysis
  
  Accutest delivers high quality bioanalytical solutions for even the most demanding studies helping sponsors accelerate approvals while maintaining scientific excellence.