Agreed. I wrote about this a few times about an year ago that you really need an in house regulatory expert to help navigate (plan ahead) and manage this ship. Otherwise you end up discovering things late in the game and in the process end up losing quite a bit of time. Outside regulatory consultants are great but their motivations, incentives, goals are quite different from someone within the company.
I have personally seen the impact of this up close, both good and bad, in medical device companies (big and small) I have worked with over the last 20 years.
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