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How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the www.fda.gov. Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.
Recently, a company called Graematter raised nearly a million dollars to develop a solution. Graematter’s SOFIE Regulatory Intelligence System is intended to help companies “use this system to develop regulatory intelligence and create superior submission strategies instead of spending much of their time hunting for facts and data”.
If you want to know more take a look at this article from Regulatory Focus that goes into more detail about the motivation for this software system and its abilities.
- Sherri
Image Credit: thisisbossi @ Flikr
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