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Bioanalytical Method Validation – FDA & EMA perspectives
ICH M10 is a very welcome, comprehensive document and provides much clarity in the area of bioanalytical validation. An overview of comments has recently been published and the industry are awaiting notification of next steps.
Our bioanalytical team within Almac are fully aware of this guidance and are dedicated to providing top quality, specialist bioanalysis and pharmacokinetic analysis services at every stage of your product development cycle from discovery to pivotal clinical studies.Download Contact us