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 FDA clears Ionis drug as first therapy for rare disease FCS Ionis Pharma's Tryngolza (olezarsen) has become the first FDA-approved drug therapy for adults with rare disease familial chylomicronaemia syndrome.
Digital Sponsored The AI effect in pharma commercial strategy: From data to re... Discover how AI is transforming the pharma commercial strategy. Unlock real-time insights & actions from data. Click here for more.