Standalone Analytical

  • Analytical method development for API & drug product as per QBD

  • Method validation and transfer to manufacturing site in line with ICH

  • API verification, vendor selection and transfer of Analytical methods to customer site

  • Development and validation of cleaning methods to support manufacturing site

  • Innovator characterization studies

  • Reverse engineering studies of the innovator product

  • Stability studies as per ICH guidelines

  • Batch screening for Bioequivalence studies

  • Cleaning method development and validation

  • Complete development and validation report in CTD format M2 and M3