Practical Strategies for ICH Q14 and Q2(R2) Compliance
The recent adoption of ICH Q14, Analytical Procedure Development, and the revised ICH Q2(R2), Validation of Analytical Procedures, effective since June 2024, represents a significant evolution in regulatory expectations for analytical procedure development, qua
Enterprise Wired: From Insight to Impact—How Cathy Konidas is Cultivating People and Driving Progress
How Clinic-Ready Manufacturing and Adaptive Clinical Trials Can Reduce Drug Development Timelines
The complexities of active pharmaceutical ingredient (API) formulation, product testing, and documentation requirements can hinder the speed at which a promising drug candidate progresses to and through clinical trials.