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 […]
Right the first time!
Talking with Michelle Lott, it was immediately clear establishing a new quality management system from scratch (with her) was the […]
lean RAQA is highly collaborative, which is precisely what you need for a strategy instead of a bunch of regulatory […]
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 […]
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.”
Knowledgeable, professional, and I enjoy her!
Michelle provided us with an excellent quality system plan. She’s knowledgeable, professional, and I enjoy her!
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 […]
Before Oprah came Michelle
Way before Oprah selected our gLOVE treat for her O List, and way before Paraffin quadrupled in size, there was […]
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 […]
Michelle’s regulatory strategy work gave us a competitive advantage. I recommend her without hesitation.
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 […]
From zero to 60!
From zero to 60. Michelle is fast and good. In under two weeks, her due diligence helped us decide if […]
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 […]
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, […]
Michelle Lott is my absolute definite go-to for FDA consultation and regulatory support. In my experience so far, she is […]
Thank God for Michelle.
She kept our regulatory strategy on track despite our changing priorities, business goals, and management team!