Do all animal studies have to be GLP compliant?

H

HeatherC-S

#1
Hello. I am working for a medical device company and are in the pre-clinical investigation phase. We are contacting some CRO's to perform some in-vivo pig work for us and the question we have is does the CRO need to be GLP compliant for this type of study? Many thanks
 
Elsmar Forum Sponsor
J

JHC928

#2
If you plan use the data to support an FDA application, you should strongly consider conducting the study under 21 CFR 58 particularly if you are collecting safety data. If study is discovery or prototype testing that won't be used in support of the application (but included in the design history file), you don't need full GLP compliance.
 
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