I have seen some VERY dysfunctional organizations in my day.
No matter the size or how long the company has been in business, if the organizational culture does not support regulatory as a strategy, then the path to product launch will be long and more difficult.
I have seen, time and time again, that companies that embrace regulatory from the beginning are more successful more quickly than companies that do not.
RAQA Today Podcast with Mitch Robbins: The Impact of Private Equity on the Life Science Industry
In this episode of the RAQA Today podcast with Mitch Robbins, we discuss the impact of private equity and venture
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Why Investors Need to Know About the FDA Product Code
The company has a great pitch, the financial projections look great, the device concept makes sense, and the presenter is
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Be Aware of These Pitch Mistakes
As an investor, when the company making the pitch says “We are a Class I, II and III device!” your
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Michelle Lott and the leanTeam help clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. The expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
