The Five Stages of Regulatory Grief
Meet your grief counselor, Michelle Lott, RAC
Hi, I'm Michelle, thank you for visiting my site today. You probably wouldn't be here if you didn't need some kind of regulatory help.
(a) make RAQA answers sound less intimidating in a Southern accent and
(b) give you a no-obligation way to determine if my seven humans and two dogs, "R&D" and "Quality," are a good fit for you.
Go ahead, just put time on my calendar.
Now, about those Five Stages? Yes, I've been through the Five Stages with clients so often I'm practically a grief counselor.
I can guide you through those first four stages or, if you're already at the "Acceptance" stage, we can jump right in. We'll develop on a solid regulatory strategy – not just a plan to "get through it" – but a strategy to widen your competitive advantage over the competition.
And hey, I'm not for everyone.
If, after our call you think, "Thanks anyway," no problem.
I grew up in the South, bless your heart. ❤
Either way and since you're here, go ahead and just get a copy of my Regulatory Pathway Assessment.
Why? Because it's a free 13-page guide to ensure you're at least looking in the right places for the regulatory questions you didn't know would be on the test.
Trust me on this. Get the 13-page guide now, while you're here.
It's worth your email address and I promise I won't spam you. I don't have time to write spam and you don't have time to delete it.
Want to learn more about me? Then read on, my new friend.
- FDA Advisor: Serving a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). Reviewing feasibility and reasonableness, recommending proposed good manufacturing practice regulations in manufacturing, packing, storing, and installing devices.
- Founder and principal: Lean RAQA Systems (since 2010). By 2018, supported more than 100 companies with services including regulatory strategy, regulatory submissions, quality systems compliance, due diligence, and a considerable range of technical support services.
- Education: Northwestern's Kellogg School of Management (Regulatory Affairs Professionals Society certification); Troy State University (BS, Chemistry)
- Interesting fact: Formerly an expert witness in forensic toxicology at the Mississippi Crime Laboratory.
- Weakness: Anything barbecued. And tequila. Lots of tequila.
- Particularly good at: Supporting startups' first quality system and submission. Remediation services for large companies, too.
Don't make me blush!
Some awfully nice clients say some awfully nice things about Michelle. Read their testimonies.
+ Michelle +