Strategic Analytical Developments

    • 01
      Active’s Characteristics in a Drug Product
    • 02
      Physical, Chemical Characteristics of Excipients – Assessment and Compatibility Studies
    • 03
      Q1, Q2 and Q3 Studies (Generic and RLD Comparison)
    • 04
      Polymorph Quantification (as Impurity or Binary Mixture)
    • 05
      Characterization of Unknown Impurities and Elucidation of Structures
    • 06
      Extractables of Packaging Components
    • 07
      ICH Q3D – Elemental Impurities (Risk Assessment)
    • 08
      Toxicological Assessments
    • 09
      Carryover Impurities’ Assessment
    • 10
      API Sameness Studies
    • Studies on Complex Formation Assessment in Formulation
      11
    • Isolation/Separation/Characterization of Chemical Substances/Impurities/Ingredients
      12
    • Polymer Qualifications (Qualitative and Quantitative) using GPC
      13
    • Method Development (all Segments based on Critical Needs)
      14
    • Method Validations as per ICH Q2 Guidelines
      15
    • DMF/ANDA Support for Documentation/Experiments/Characterization
      16
    • Impurity Profiling of API’s, Intermediates and FDF’s
      17
    • ICH M7 – Genotoxicity Prediction and Assessment (API Projects and Others)
      18
    • Risk Assessment for BA/BE Failures
      19