Thinking Kat: June Roundup

Here are the stories you may have missed this month!

Photo by Carol Highsmith's America on Unsplash

BONUS: I host a live chat in Substack every Friday at 9am PST. This is exclusive to my Substack subscribers! Questions? Don’t hesitate to reach out.

First up, I covered a topic that many founders overlook in the early days of their startups. That’s a mistake that could come back to haunt them. Solid documentation helps you win grants, impress investors, and get your product to market. Learn about the why, what, how, and when of good documentation practice (GDP) in this article.

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KOLs, or Key Opinion Leaders, are the trusted experts whose opinions shape the life science industry. They are essential for startups to build credibility and create your path to market adoption. Investors and potential partners listen to KOLs because hey trust their judgment and look to them for validation of new solutions. Learn more by watching this video!

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We wrapped up June with a deep dive into a necessary evil for cGMP manufacuterers - regulatory inspections. Navigating an FDA inspection can be one of the most stressful events for any drug or medical device manufacturer—but with the right preparation, it can also be a powerful opportunity to showcase your team’s commitment to quality and compliance. This article breaks down the essential steps every organization should follow before, during, and after an inspection to ensure the best possible outcome.

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Working with life science startup companies to solve problems, strengthen systems, and build capacity is what I do. If one of your companies or clients is struggling, reach out to me to discuss how I can help your team refocus and emerge triumphant.

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