Our AR&D team have a thorough understanding of latest regulatory requirements, relevant chemistry and analytical techniques that are critical in developing efficient, accurate, robust analytical methods by systematic approach.

The analysts interact closely with chemists to understand the process requirements process changes with respect to mole equivalents of RMs, dilutions, sensitivity / stability of reagents, intermediates and products and swiftly develop ‘fit for the purpose’ analytical methods. Special emphasis is placed on the first critical activity, sampling, and sample preparation, for accurate estimation. The team has rich experience in developing methods for chiral compounds, non-chromophoric compounds, and expertise in developing the sensitive methods for Genotoxic impurities (GTI) and Nitrosamines as well as handling complex sample metrics and high molecular weight substances. The structural identification and characterization of the compounds is integral part of the analytical method development.

The analytical methods are validated by dedicated qualified team as per phase appropriate requirements and ICH norms under GMP with QA supervision. In the process of analytical method validation, team will execute the activities in line with client requirements including protocols and reports review and approval.