SOPs applicable for Regulatory Affairs department

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Ronen E

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#2
Hi,

I want to know what are the process that should be documented under Regulatory Department?
Why do processes need to come under specific departments?...

Personally, I'm not even sure a "Regulatory Department" is necessary. To me it makes much more sense (and less politics, and less silo-ing) to have a QA & RA department.
 
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