Post by ICON plc

Because combination products do not fit neatly into a single category, their regulation can be difficult to navigate. However, there are several broad strategies that can help guide planning for drug-device combination products. Our latest article by ICON’s Global Head of Regulatory CMC, Venkat Sunkara, MSc, MRSC outlines three practical CMC strategy pathways and highlights where regulators are placing increasing focus, from interface quality attributes to change management. Learn how to position your product for success: https://ow.ly/kkmQ50ZbSZW #DrugDevice #RegulatoryScience #Pharma #MedDevice #QualitySystems #ICH #ProductDevelopment