Regulatory + Quality Assurance | Michelle Lott | lean RAQA

The Five Stages of Regulatory Grief

To many, coming to terms with regulatory requirements and changes is like going through the Five Stages of Regulatory Grief.

The Five Stages of Regulatory Grief

Denial: You're telling me we have how many requirements? That's ridiculous. Go find out what we have to do – the bare minimum.
Anger: What are these regulators even thinking? How is anyone supposed to innovate with all these regulations? I don't even know if I want to continue! This will take forever!!
Bargaining: Okay, I'm calm now. We can do this. Maybe we can just do these few and do the rest over time?
Depression: Oh my god. I have to meet ALL of these requirements. Up front. I don’t know we'll do it. I'm: (a) going back to bed, (b) going for a run, (c) going to get a drink.
Acceptance: I can get my head around this now, and I clearly need help if I'm to commercialize on time, make money, and keep patients safe.

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.
I'm happy to dedicate a half hour to: (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.

About Michelle

  • 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.
  • 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 +