Combo Products, Complex Rules: Regulatory Strategies for Combination Products

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in Life Sciences and Regulatory Affairs. This time, I’m joined by Plamena Entcheva-Dimitrov, PhD, RAC, founder of  Preferred Regulatory Consulting.Combination Products DemystifiedCombination products are more than the sum of their parts. From pre-filled syringes to gene therapies delivered via light-activated devices, these innovations span multiple product types as well as complexity levels. These variations and complexities can make a product's Regulatory journey challenging. Plamena walks us through the practical realities of navigating these challenges, with a few tips on how to make the journey a little less bumpy.Our top resources: Understand combination product requirements. Read the global strategy essentials blog Align regulatory and quality from day one. Watch the Med Device RIM & QMS session Pharma-first RIM systems don’t work for devices. Learn about what you need instead