Industry Insights

1. The PMCF Decision Guide 10/14/2026

   Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.

2. Accelerating Enrollment For Direct-To-Patient Observational Studies 10/14/2026

   Removing the handoff between patient self-screening and enrollment changes what a fully virtual observational study can achieve, from conversion at peak intent to completion rates among participants.

3. Getting Ahead Of PFAS Risk In Pharmaceutical Manufacturing 10/14/2026

   Pharma can’t simply eliminate essential PFAS uses. A phased, risk-based strategy can address footprint, exposure, and supply risks amid regulatory uncertainty.

4. PFAS In Medical Devices: What's New And What To Do 10/14/2026

   Regulators now separate fluoropolymers from other PFAS, but lifecycle risks remain. Readiness starts with knowing which uses, reporting duties, and exposures matter most.

5. A Risk Management Approach For The Pharmaceutical Industry 10/14/2026

   Replacing fluorinated chemistries across pharma isn’t simple. Growing pressures make it critical to prioritize risks and take a sequenced, evidence-based approach to mitigation.

6. Your Quality Team Is Already Using AI To Draft Compliance Documents 10/8/2026

   Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect governance, and the gap is an undocumented process step, not unreliable output.

7. Why Passing Audits No Longer Predicts Scale 10/8/2026

   Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.

8. Why Audit Success No Longer Predicts Clinical-Stage Performance 10/8/2026

   Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

9. 5 Hidden Risks In Manual Life Science GRC Systems 10/8/2026

   Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to scalability limits, that tend to surface only when an inspector finds them.

10. Navigating Recent Changes To USP <788> 9/29/2026

    A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.