Our analytical, research and development teams have a thorough understanding of latest regulatory requirements, relevant chemistry and analytical techniques which are critical in developing efficient, accurate, and reliable analytical methods.

The analysts interact closely with chemists to determine the exact requirement in order to swiftly develop 'fit-for-purpose' analytical methods. Special emphasis is placed on the first critical activity, sampling and sample preparation, for accurate estimation. The team has extensive experience in developing methods for chiral compounds, non-chromophoric compounds, as well as handling complex sample metrics and high molecular weight substances. Structure identification and confirmation of intermediates and impurities is an integral part of the analytical method development.

The analytical method is validated by a separate and dedicated team under QA guidance and supervision. The comprehensive analytical method validation protocols are prepared by the validation team and subsequently reviewed and approved by our quality assurance department. Relevant regulatory guidelines and work plans are closely adhered to during this process. The protocols are shared with the customer, for their review and approval.