Co-founder and CEO of Regller AI. Biswas has more than 25 years of leadership experience across life sciences and technology, with expertise in manufacturing, quality and compliance, and enterprise-scale digital transformation. His experience spans manufacturing site design, commissioning and qualification, computer system validation, pharmacovigilance, and global manufacturing shop-floor operations.
A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.