Method Development

  • According to FDA guidance, method development is an activity designed to create an analytical procedure “to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic.”
  • Where method development may be performed for non-regulatory purposes, it can be very important to develop a method with an eye toward validating it in the future.
  • Immense Culture has been taking method development projects and has been delivering it smoothly and also these methods have been validated by clients.