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Re: vator post# 584617

Wednesday, 04/12/2023 10:48:35 AM

Wednesday, April 12, 2023 10:48:35 AM

Post# of 705461
Agreed. They want to bill and milk as much as possible even though milestone based payments are part of some of the contracts. And it’s easy for these guys to take slight advantage of the situation when the other party have absolutely no idea what the hell is going on and what’s required.

I have worked with FDA, EU, and Asian regulatory consultants on the medical device side. While they are quite helpful in avoiding traps for unwary, keeping you abreast with the latest requirements and standards, verifying your documentation, and so on, it’s worth noting that they are also working with many biotech companies in parallel and the onus always falls on the company personnel to move the needle.

I reported a few times couple of years ago that they will struggle during the RA processes and will end up losing a lot of time without someone like Duffy given their inexperience.
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