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Sarah Green

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ANDA owner question

Posted By Sarah Green 17-Oct-2018 11:40
Found In Egroup: Regulatory Open Forum \ view thread
Hello Everyone, Is it possible that the owner of an ANDA be a corporate office?  The corporate office would not do any manufacturing or perform any testing services, but would manage facilities that do manufacture and perform testing. Thanks, Sarah ------------------------------ Sarah Green ...

RE: ANDA owner question

Posted By Sarah Green 17-Oct-2018 09:37
Found In Egroup: Regulatory Open Forum \ view thread
Thank you.  Would this be an administrative change? ------------------------------ Sarah Green Knoxville TN United States ------------------------------

Doc mgmt software

Posted By Sarah Green 13-Mar-2018 13:06
Found In Egroup: Regulatory Open Forum \ view thread
Hello, Can anyone recommend document management software that is compliant with 21 CFR part 11? Thanks, ------------------------------ Sarah Green Knoxville TN United States ------------------------------

How to import?

Posted By Sarah Green 13-Jul-2017 13:14
Found In Egroup: Regulatory Open Forum \ view thread
Does anyone the process to import a radioactive drug in the US? ------------------------------ Sarah Green Cyclomedical International Inc. Knoxville TN United States ------------------------------

Additional manufacturer question

Posted By Sarah Green 13-Jul-2017 13:08
Found In Egroup: Regulatory Open Forum \ view thread
When an additional manufacturer is added to an approved ANDA and later that manufacturer no longer wants to be "additional", do they have to submit another ANDA or would this be an administrative amendment? ------------------------------ Sarah Green Cyclomedical International Inc. Knoxville TN ...