Originally published November 2025.
Welcome to Insider issue #43.
Also, hello to the 144 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
This month brings guidance that reshapes how drug facilities prepare for pre-approval assessments. Alternative tools—remote regulatory assessments, foreign partner inspections, remote subject matter experts—aren’t just emergency options anymore. They’re becoming business as usual.
For medical device and combination product companies, the September 2025 Computer Software Assurance guidance finally provides clarity on risk-based software validation.
The one-size-fits-all approach is officially dead. And our warning letter analysis covers Creative Essences, an OTC manufacturer whose citation illustrates what happens when curiosity fades and compliance becomes a reactive posture.
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