Our Expertise

  • Bio relevant in-vitro tests to understand in vitro behavior of products and development of IVIVC/R.
  • Bio study strategy comprising of suitable study design, sampling points, protocol and number of volunteers.
  • BA/BE studies involving in vitro end points, PD end points, special population and patients.
  • Bio waiver strategy, BCS class approach for ANDA approval, highly variable drugs & drug products