Our Expertise

  • Expertise in proposing best study design based on variability of drug and /or drug product.
  • Study protocol development that encompass all regulatory requirements and bio success.
  • Application of advanced statistical tools(boost strapping, Monte Carlo simulations etc.) to pilot studies to assess variability, number subjects, sampling points and duration of sampling.
  • Outlier tests and regulatory strategies for addressing narrowly failed BE studies.
  • Error free documentation, report writing and scientific justification writing.