Infill Life Science

Clinical

    1. BA/BE Study
    2. PK/PD Statistical Input to Protocol
    3. Clinical Trial Interim/Final Statistical Data Analysis
    4. Dissolution Data Analysis (Bootstrap; MSD, CI)
    5. Regulatory Queries –Response Preparation
    6. Sample Size Estimation
    7. Stability / Shelf Life – Extrapolation
    8. Analytical Similarity Analysis
    1. Clinical Overview
    2. Literature Survey

Non-Clinical

    1. Assessment of genotoxicity (mutagenicity) potential
    2. Per ICH M7 Requirements

Others

    1. Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE)
    2. Occupational Exposure Limit (OEL)