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.
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Denial
You’re telling me we have how many requirements? That’s ridiculous. Go find out what we have to do – the bare minimum.
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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!!
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Bargaining
Okay, I’m calm now. We can do this. Maybe we can just do these few and do the rest over time?
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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.
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. ❤
The RA part
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
This 17-page Regulatory Pathways Assessment guide (now updated with EU MDR requirements) is probably the most helpful tool I ever created.
Hundreds of downloads later, I confidently assert the guide will help you work through project feasibility and requirements with FDA and notified bodies.
And I promise I won’t spam you. Spam is a waste of everyone’s time.
Get it now!The BA part
Completely Free. No Commitments.
Business Market Assessment Guide
Regulatory compliance is a critical investment. Initial and recurring expenses take a big chunk out of your budget.
Is it worth it? Only you can answer that question, but we can help.
Our new Market Assessment tool walks you through the revenue vs. cost modeling calculations that can help you judge the market viability of your product – before you commit.
Get it now!The QA part
Completely Free. No Commitments.
21 CFR 820 Roles/ Responsibilities Guide
“The buck stops here.”
Even if another company is designing, making, and distributing your device – your quality system requirements apply to you. Authority over your device cannot be outsourced.
This 21 CFR 820 Roles and Responsibilities Guide is a tool to identify who’s responsible for complying with what. You can even attach it to your quality agreement.
Get it now!Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
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.
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.
Our Team
Our Team
Don’t make me blush!
Client Testimonials
"A “no shit” expert."
Michelle is a “no shit” expert in helping start-up companies with FDA. She sits on an FDA advisory committee, helped
"Before Oprah came Michelle"
Way before Oprah selected our gLOVE treat for her O List, and way before Paraffin quadrupled in size, there was
"Confidence I was ‘doing everything right’"
Michelle’s Regulatory Pathway Assessment helped me get investment proposals, reliable cost estimates, and the confidence I was “doing everything right.”
"Expert on everything from labels to claims."
Michelle was very helpful on my PepsiCo project. So much so, I let my clients know I have an expert
"Fastest audit ever!"
That was literally the fastest FDA Audit/Inspection “ever!” He arrived, in uniform, at 9:40am and left at 10:30am with no
"From zero to 60!"
From zero to 60. Michelle is fast and good. In under two weeks, her due diligence helped us decide if
"Highly collaborative!"
lean RAQA is highly collaborative, which is precisely what you need for a strategy instead of a bunch of regulatory
"Knowledgeable, professional, and I enjoy her!"
Michelle provided us with an excellent quality system plan. She’s knowledgeable, professional, and I enjoy her!
"Right the first time!"
Talking with Michelle Lott, it was immediately clear establishing a new quality management system from scratch (with her) was the
"Some kind of ‘Wonder Woman!’"
Michelle is some kind of “Wonder Woman.” How else to describe her layered risk-management remediation plan that weathered three days,
"Thank God for Michelle."
She kept our regulatory strategy on track despite our changing priorities, business goals, and management team!
"The Best Regulatory Affairs Consultant"
Michelle is the best regulatory affairs consultant I have found in Arizona, maybe beyond. She is very experienced in drugs
"Top notch."
Michelle Lott is my absolute definite go-to for FDA consultation and regulatory support. In my experience so far, she is
"What a worthwhile investment!"
We brought Michelle for full-day risk management training and got much more, including an insight on IVDR requirements that we
"Without additional resources or effort!"
By creating procedures and documentation around existing but previously undocumented processes, Michelle developed an easy-to-use, implement, and maintain system without
"Without hesitation."
Michelle’s regulatory strategy work gave us a competitive advantage. I recommend her without hesitation.
