The Regulatory Leadership Briefing
Insight & News
Field notes on the rules that move markets — written by the people who do the work.
Connor Griggs · 8 min read
The Regulatory Leadership Briefing
Field notes on the rules that move markets — written by the people who do the work.
Connor Griggs · 8 min read
The Ledger
Practical guidance on the regulations reshaping your work — written to be applied, not just read.
3 articles
The European database has been voluntary for years. A 2025 Commission decision set the clock for mandatory use — and the work that decides whether you make it is the data you don't have yet.
Connor Griggs · 8 min read
Established conditions, PACMPs, and the PLCM document are levers, not paperwork. Why most manufacturers capture none of the benefit — and how to change that before your next submission.
Connor Griggs · 7 min read
PMS remains the most common source of notified body findings, and the pattern is consistent: paperwork where a system should be. The recurring gaps, the EUDAMED clock, and how to build PMS that survives audit.
Connor Griggs · 9 min read
The statutory 30-day clock hasn't moved — almost everything around it has. Where a leaner, reorganized FDA actually changes your IND risk profile, and how to plan the interactions that remain.
Connor Griggs · 8 min read
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