R&D Challenges of analytical method validation for ATMPs Quality control of medicinal products is a fundamental aspect of assuring the quality, efficacy, and safety of the product.
Digital DTx and the case for fit-for-purpose evidentiary standard DTx deliver evidence-based therapeutic interventions driven by high-quality software programs
Views & Analysis Moving to component management & traceability: progress, bar... Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management syste
News Bayer trial combines two top drugs for kidney disease Data from the CONFIDENCE trial shows the value of combining Bayer's Kerendia with an SGLT2 inhibitor to treat chronic kidney disease in diabetics.