Blog

Expert Analysis: Adaptive Oncology, EMA/FDA/NMPA RbM & Psychedelic MDD

A practical, patient-first analysis of adaptive oncology submissions, global monitoring expectations, pregnancy registries, and psychedelic-assisted MDD trials—focused on clarity for patients and sponsors.

Regulatory Readiness Scorecard: Cross-Border Neuro-Oncology Safety

When a severe adverse event crossed borders in a glioblastoma study, regulatory affairs specialists turned a late-night crisis into a plan with a Regulatory Readiness Scorecard that maps adaptive risks and harmonizes EMA-NMPA dossiers.

Case Studies: RWE Label Expansion & FDA‑EMA Oncology Alignment

Practical, stepwise guidance on FDA‑EMA harmonization strategies for multicenter oncology trials, RWE strategies for breast cancer label expansion, inspection readiness for flu/COVID, and cross-border approvals for university sponsors.

FDA-EMA Breast Alignment Influenza Safety Reports & Biobank Compliance

Five practical steps for regulators and research teams: align FDA-EMA breast approvals, streamline influenza safety reporting, secure biobank transfers, and prepare university trials for inspections.