- 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.