Startup Regulatory Strategy 101: Avoiding Costly Delays & Fines
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Startups often move fast, but moving too fast in a regulated industry can kill your business. Today, we sit down with regulatory expert Aaron Harmon to discuss the hidden rules of product oversight. We cover why waiting until "someone knocks at your door" is a terrible strategy and how seemingly harmless products (like mobile apps or even orchids) can trigger federal investigations.
Aaron breaks down the timeline for spending money on compliance. He explains why you shouldn't burn cash on high-priced consultants before you have a proof of concept, but why waiting until clinical trials to think about paperwork can cost you millions. We also explore how to draft a written regulatory strategy that keeps your entire team aligned.
Aaron has worked in the biologics, drugs, and medical device industry for 20 years. He spends his free time researching the history of healthcare product regulations and sharing through his podcast Regulations Rx. He also educates and studies the impact of these regulations through Mount Marty University's Regulatory Science Master's Program.
To learn more about Mount Marty University's Regulatory Science Program, visit here: https://www.mountmarty.edu/academics/majors-and-programs/master-of-science-in-regulatory-science/master-of-science-in-regulatory-science/
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