Innovating for 503A Growth: Clinical Trials


Manage episode 295745172 series 2934602
By Vivian Juter Frankel. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

My guest today is from Infuserve America, a 503A that has a division that focuses on investigational drugs, otherwise known as clinical trials. I was first introduced to this idea by some associates at a pharmaceutical company, they told me how they struggled to find 503A's to work with due to a variety of reasons. Some are because of misconceptions on the regulatory issues. Some are due to perceived GMP standards that they think a 503 a couldn't possibly attain. So I was really looking forward to this conversation. They've been working in this space for years and was able to shed light on how they got into this area, and what it's been like working on clinical trials with a variety of organizations.

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