Bioequivalence Studies

  • The Clinical phase is conducted at our affiliated clinical sites
  • The Bioanalytical phase is conducted at affiliated Laboratories, accredited & validated, with extensive experience in bioanalysis & state-of-the-art instrumentation & technology

Study design & protocol development

Clinical phase

  • Subject recruitment
  • Blood sampling
  • Sample handling
  • AE reporting


  • Analytical method development & determination of active compounds in biological fluids
  • Bioanalytical method validation assay methods


  • Determination of pharmacokinetic parameters
  • Pharmacokinetic modeling & simulation


  • Data management
  • Statistical programming & analysis

Integrated clinical study report

  • Clinical, bioanalytical, pk, biometrics reporting

Submission to regulatory authorities, follow-up of the approval procedures & expert opinion

Accessibility Toolbar