Of Counsel Heidi Sorensen was interviewed on the Thinkset Podcast, “Episode 24: Katie Norris and Heidi Sorensen – Commercialization Risk and Compliance,” about compliance considerations companies should factor into their strategy and planning when they are entering the U.S. market from abroad or preparing to commercialize an FDA-regulated product.
Sorensen said some of those considerations include what the company’s key compliance risks are, any payer considerations, and the applicable rules, regulations and guidance from the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, and any state regulators or licensing boards. She said the company will want to create a program that will address those risks and that the program it creates has to be scalable.
“So, having a program that can scale up as the product becomes bigger and has more of a market is very important,” she said. “And then, finally, making sure that your employees are trained and understand the goals of the compliance program and how it fits into the company’s business goals.”