Some information is available publicly (the FDA and other databases), but due diligence is the best way, starting by directly asking the CRO about their inspection history. During the vendor qualification audit, they should be able to provide you a redacted copy of the 483 or other audit reports over the past several years. These will give you a good idea about their commitment to regulatory compliance.
Harri Jarvelainen, DVM, PhD, MBA, DABT, ERT, Adj Prof
http://www.biotechgo.com/
https://www.linkedin.com/in/pharmaentrepreneur/
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Harri Jarvelainen
Beijing
China
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Original Message:
Sent: 17-Oct-2023 13:31
From: Meredith Brown
Subject: qualifying a CRO for nonclinical studies
Is there a way to find out if a potential nonclinical CRO has had issues with regulatory compliance in the past?
-Anononymous member
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