Regulatory
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Dawn joined the group
Regulatory 2 days ago -
Holly started the discussion Manufacturing and Import Authorization – UK in the forum Regulatory 3 weeks ago
Manufacturing and Import Authorization - UK
Hi everyone – I have a combo product question for ya. Does anyone know what all is required for a UK manufacturing and import authorization of investigational medicinal products if the manufacturer is located in the US? The guidance is a bit confusing as it seems to only focus on manufacturers located in “approved countries” which, as far as I…
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Joe replied to the discussion eMDR Gateway set up in the forum Regulatory 2 months ago
Yeah hey Jude, seems like these guys have you in good shape, but there is an eSubmitter software you can download and after that you should he able to directly access the gateway from your desktop. But once inside, you can select the option for FDA form 3500A.
If you also need help with assigning any of the codes associated with any MDR, let…
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Jeff replied to the discussion eMDR Gateway set up in the forum Regulatory 2 months ago
Hi Jude, happy to help as well. Here is a link to the FDA’s page for the ESG NextGen:
If you have additional questions or want further pointers, please reach out directly.
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Melissa replied to the discussion eMDR Gateway set up in the forum Regulatory 2 months ago
Hi Jude. Yes, I can help you out – let’s connect directly!
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Jude started the discussion eMDR Gateway set up in the forum Regulatory 2 months ago
My client has the need to set up and begin submitting MDR’s. The guidance mentions an ESG Next Gen gateway. I have never set this up. Does anyone have experience with this and can provide some pointers.
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Dulciana joined the group
Regulatory 2 months ago -
Ash replied to the discussion IVDR Metrological Traceability in the forum Regulatory 3 months ago
Reply to IVDR Metrological Traceability
Hey Holly, sorry, I meant the metrological traceability section. No screen shot, we don’t have any verbiage for it yet.
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Ash replied to the discussion IVDR Metrological Traceability in the forum Regulatory 3 months ago
Reply to IVDR Metrological Traceability
It is a standalone control used to verify calibration of clinical lab equipment. The NB seems to want to see metrological traceability back to the original control material or some statement to that effect in the IFU.
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Holly replied to the discussion IVDR Metrological Traceability in the forum Regulatory 3 months ago
Reply to IVDR Metrological Traceability
Hi Ash, also not sure if you intended to include any type of screenshot or anything but what specifically in the IFU were they pushing back on? Thanks!
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