Angeles Escartí-Nebot

PhD · Global Head Regulatory Affairs at QbD Group

Angeles has built her career at the crossroads of science and regulation. From academic research at CNB and CNIC to leadership roles in biotech and global consulting firms like Asphalion, Parexel, Pharmalex, and Scendea, she translates regulatory complexity into action. She has a strong track record of building and scaling teams, and is especially focused on the intersection of data, AI, and regulation to unlock faster healthcare innovation.

7 articles

Regulatory Affairs14 abr 2026 5 min

EU and UK Regulatory Submissions: Platforms, Authority Interactions and Timeline Control

Entering Europe after FDA approval? Learn how to manage EU and UK regulatory submissions, authority interactions, and submission timelines efficiently.

Regulatory AffairsPharmacovigilance12 abr 2026 6 min

Operational Readiness for Europe: PV, QA and MAH Requirements Biotechs Cannot Ignore

Entering the EU market requires more than approval. Discover the pharmacovigilance, quality, and MAH requirements biotechs must prepare before European launch.

Regulatory Affairs4 mar 2026 4 min

Scientific Advice for Startups: Turning the Right Questions into Regulatory Clarity

Scientific Advice is one of the few moments in early development where a biotech can test its assumptions with regulators. Learn how to structure questions, integrate CMC and clinical strategy, and leverage EMA SME support for maximum impact.

Regulatory Affairs4 mar 2026 4 min

Pre-Submission Optimization for EU/UK: How US Biotechs Can Adapt FDA Packages Efficiently

For US biotechs expanding into the EU and UK, successful submission conversion requires early planning, clear ownership, and a structured approach. Learn how to build a reuse map, manage parallel conversion tracks, and avoid late-stage rework.

Regulatory Affairs18 feb 2026 4 min

Planning EU Expansion: What US Biotechs Must Get Right From Day One

Planning EU and UK expansion as a US biotech? Learn which regulatory, clinical and operational decisions matter from day one.

Regulatory Affairs13 feb 2026 3 min

Deciding Early on an Orphan Strategy: A Strategic Choice, Not a Checkbox

Orphan strategy decisions go beyond incentives. Learn how regulatory definitions, evidence requirements, timing, and exclusivity across the EU, US, and UK shape early biotech development strategy.

Regulatory Affairs4 feb 2026 2 min

Strategic Choices That Define a Biotech's Path to the Clinic: First-in-Human Is Earned Long Before It Begins

Early strategic choices define whether a biotech reaches first-in-human smoothly. Learn how EU/UK regulatory, CMC and quality decisions shape success.

Usamos cookies para mejorar tu experiencia

Usamos cookies esenciales para el funcionamiento del sitio y cookies de análisis opcionales para mejorar nuestros servicios. Consulta nuestra Política de privacidad y Política de cookies.