Early phase and BA/BE studies

  • Phase-I studies .i.e. First-in-Human / First-in-Patient, and Healthy Volunteer Studies
  • PK/PD studies
  • Drug-Drug Interaction Studies
  • SAD/MAD studies
  • Food Effect Studies
  • Special Population (like Hepatic and renal impairment studies)
  • Bioequivalence/bioavailability studies

Our comprehensive bioavailability (BA) and bioequivalence (BE) studies service incorporates regulatory consulting, protocol design, ethics committee submissions, a clinical pharmacology unit, and bio analytical testing. We also offer expertise in clinical study management, method development and validation, PK analysis, statistical analysis and report writing. Our centers are approved by all major regulatory agencies.