Michelle Lott is the Founder of Lean RA QA, an organization that provides organizations across the life sciences with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services, and grief counseling! As we all know, working with regulators is tough stuff.
Michelle also serves on the FDA Device Good Manufacturing Practices Advisory Committee.
During this episode, Michelle discusses her insights as it relates to Private Equity and Venture Capital in the Life Sciences.
Some of the highlights we cover:
-How the rapidly changing Regulatory environment is impacting investments in the Life Sciences
-What type of Regulatory information you can gleam even before a detailed design or prototype
-Factors to indicate whether a company will have a successful exit
-Trends in the M&A space within the Life Sciences
Michelle and Lean RA QA can be found at leanraqa.com
Today we roll out another RA/QA Today podcast episode featuring Ms. Gowri Sukumar who is the Director of CMC and Regulatory Affairs for Betacat Pharmaceuticals in Houston, TX.
Gowri has a breadth of experience spanning across R&D, CMC, and Regulatory Affairs. Simultaneously, she serves a reviewer for several Bioscience journals across the world.
The topic we covered is "How to set specification limits for impurities in active pharmaceutical ingredients (API)."
Some of the items we cover in the episode:
-The first step to setting these specifications
-The most important tool to setting this specification
-What is acceptable and what is not considered acceptable specifications
...and so much more