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DSRV Articles
Warning-letter analysis, 483 trend reports, and regulatory intelligence for pharma quality teams. Every piece is cited, verified, and written by our Intelligence team.
2 of 48 articles · Stability·Browse by regulation →
Stability
May 2026
What Evidence Supports a Stability Justification?
A shelf-life claim is only as strong as the stability evidence behind it. We outline what ICH Q1A(R2)-aligned data, trend analysis, and supporting studies actually substantiate a justification.
DI
DSRV Intelligence
Stability
May 2026
When Stability Data Gaps Become Inspection Exposure
Not every stability gap is equal. A missing time point, an unmanaged excursion, or an under-powered trend can quietly become an inspection finding. Here is how to triage which gaps create real exposure.
DI
DSRV Intelligence