It has probably been a month and a half by now. When I was there it was a production audit but I don’t know how much more needed to be done. I will say I have to do private label work for my job and I am dealing with much much smaller companies than Bayer and it’s a pain in the neck. Would be nice to know where they are in this partnership.
I think a deal is contingent on BIEL getting FDA clearance.
(In my opinion)
With a company like Dr. Scholl's (or Bayer), their procedures would likely dictate a 3rd party vendor/supplier audit. Look up GMP supplier audit, or QSR 21 CFR Part 820 audits to be more technical.
That is to say a big pharma company would likely want to look into a myriad of things at BIEL related to their operations, finances, manufacturing controls, quality, and compliance.
IMO, an executed deal with BAYER for example COULD mean that BIEL had their stuff together enough to satisfy a pretty serious external audit.
Of course, you could just ask Paul or BIEL if they have gone through or are currently in process of going through vendor/supplier audits related to QSR 21 CFR p820 with any potential US Distributors. If they were, I'd assume they have NDA or something in place so they probably couldn't tell you outright, but they might have a creative answer or something?
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