DATE/TIME
September 25, 10:15 – 10:45 AM EST
TITLE
From Approval to Availability: Strengthening the Regulatory-Supply Chain Connection
SPEAKER
Dhaval Desai, Director of Regulatory Affairs & Supply Chain, Zydus Pharmaceuticals
ABSTRACT
This session will examine the connection between regulatory affairs, supply chain planning and external manufacturing partnerships as pharmaceutical products move from approval toward launch and ongoing market availability. Dhaval Desai will discuss how companies can better coordinate regulatory readiness, supply continuity, CDMO oversight, launch planning and risk management to support product access, manage disruption and respond to changing market and compliance expectations.
BIO
Dhaval Desai is a distinguished pharmaceutical executive with over 15 years of expertise leading regulatory strategy, pharmacovigilance, and supply chain resilience. As Director of Regulatory Affairs and Supply Chain, he oversees generic and specialty product portfolios across U.S. and international markets, having served as lead strategist for more than 65 FDA drug approvals and spearheaded critical drug shortage mitigation initiatives in collaboration with the FDA.
A recognized industry thought leader and published author in the various publication including Journal of Regulatory Affairs, Dhaval serves on the AAM Scientific Regulatory Advisory Working Group and Generic Animal Drug Alliance, contributing as key subject matter expertise to shape policy across human and animal health sectors. He holds an MBA in Pharmaceutical Management from Fairleigh Dickinson University and a Bachelor of Pharmacy from Gujarat University.
