Dragone Consulting is a founder-led independent advisory practice supporting pharmaceutical, biotech, life sciences and CDMO/CMO organizations, as well as consulting and technology partners.
The practice combines senior Pharmaceutical Quality & GxP expertise with a differentiated focus on the responsible use and governance of AI/GenAI in regulated Quality environments.
Quality is the foundation. AI/GenAI is the differentiated extension.
Senior Quality judgement where regulated work, governance and decisions require clarity, evidence and accountable ownership.
Senior independent advisory and SME support across Pharmaceutical Quality Systems, GMP compliance, inspection readiness, investigations/CAPA, change control, QRM, remediation, external supply/CDMO oversight, supplier governance, QP/product release and data integrity.
Quality-led, technology-neutral advisory focused on where AI/GenAI enters regulated work and decision-making, including intended use, Human Oversight, accountability, evidence, challenge, escalation and decision defensibility.
Independent specialist support for regulated organizations, consulting firms and technology partners requiring senior Pharmaceutical Quality/GxP expertise or a governance layer around AI-supported processes.
Practitioner-led learning focused on how professionals use, verify, challenge and govern AI/GenAI when it enters real Pharmaceutical Quality work and regulated decisions.
Foundations, responsible use, opportunities, limitations and appropriate-use boundaries in QA and GxP workflows.
Verification, source validation, critical review, evidence trails and applications to investigations, CAPA, change, risk and document review.
Decision-point mapping, accountability, decision ownership, evidence, challenge, uncertainty, stopping rules and escalation.
Use-case readiness, controlled pilots, acceptance criteria, role clarity and Go / Modify / Stop decisions.
Founder & Principal Advisor, Dragone Consulting.
Senior Pharmaceutical Quality executive and independent advisor with 30+ years of experience across multinational pharmaceutical companies, manufacturing sites and external supply networks.
His work combines Pharmaceutical Quality & GxP experience with a differentiated focus on the governance of AI-supported work and decision-making in regulated environments. The approach is Quality-led, decision-first and technology-neutral.
Alongside advisory work, he develops and delivers practitioner-led executive education focused on AI/GenAI in Pharmaceutical Quality & GxP, Human Oversight and AI-supported Decision Governance.
For advisory, executive education, faculty, speaking or specialist collaboration opportunities, contact Damiano Dragone directly.