They are not the same thing at all. Or are they? The FDA may think so, and it can impact your clinical data and evaluation plans. Listen in as Greg Kunst and I explain the differences…..and the similarities.
Michelle Lott helps clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. Her expert team will also strip away any redundant or misdirected activities so you can focus on what really matters: Winning in the marketplace!