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.
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Immense Culture has been taking method development projects and has been delivering it
smoothly and also these methods have been validated by clients.