DATE/TIME
September 25, 09:00 – 09:30 AM EST
TITLE
Before FDA Pushback: Using Regulatory Intelligence to De-Risk CMC Submissions
SPEAKER
Piyush Modi, Director, Regulatory Affairs, Amneal Pharmaceuticals
ABSTRACT
CMC issues remain one of the most common reasons regulatory submissions run into delays, particularly when gaps emerge around stability, process validation, analytical methods or manufacturing readiness. In this session, Piyush Modi of Amneal Pharmaceuticals will discuss how sponsors can use regulatory intelligence earlier in development to identify potential CMC risks before submission. The presentation will explore how better data discipline, cross-functional planning and proactive review of regulatory expectations can help reduce avoidable delays, strengthen submission packages and support more confident development decisions.
BIO
Piyush Modi, BPharm, is Director of Regulatory Affairs at Amneal Pharmaceuticals with more than 20 years of experience in pharmaceutical development, Chemistry, Manufacturing, and Controls (CMC), and regulatory strategy. His expertise spans NDA and ANDA development, lifecycle management, quality systems, inspection readiness, manufacturing change management, and global regulatory compliance across multiple dosage forms and therapeutic areas.
Piyush has supported numerous regulatory programs involving product development, approval, and commercialization. He has authored multiple publications in regulatory science, pharmaceutical development, and the emerging application of artificial intelligence to regulatory decision-making. His professional interests include regulatory intelligence, digital transformation, quality risk management, advanced therapies, and innovative approaches to improving regulatory outcomes. In his current role, he focuses on leveraging regulatory intelligence and risk-based strategies to strengthen CMC readiness, improve submission quality, and reduce avoidable regulatory delays.
