For the last two decades, life sciences companies, large and small, have relied on a handful of expert vendors to tackle the “last mile” for regulatory submissions. It genuinely required both deep subject matter expertise in Structured Product Labeling XML creation and a great deal of time to do it yourself using publicly available tools. Given how complex, tedious and time consuming building SPL submissions were, it made sense for specialized vendors to emerge and do the work mostly by hand. Labor arbitrage across geographies will only get you so far, and it creates its own set of unique challenges. As a result, the mindset has been “why spend money fixing something that ain’t broke?”

And the hours are not even the real cost. The answer cannot be reproduced. Six months later somebody asks where the number came from, the person who assembled it has moved on, the spreadsheet is still there, and nobody can defend it — so the whole thing gets done again from scratch.