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Combo Products, Complex Rules: Regulatory Strategies for Combination Products
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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 Demystified
Combination 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
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