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    • Regulatory Strategy
    • Regulatory Submissions
    • Quality Systems Compliance
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Regulatory + Quality Assurance | Michelle Lott | lean RAQA

  • Services
    • Regulatory Strategy
    • Regulatory Submissions
    • Quality Systems Compliance
    • Audits
    • Due Diligence
    • Technical Support
  • Industries
    • Medical Devices
    • Biologics
    • Drugs
  • Videos
  • About
  • FREE
Services

Regulatory Submissions

Michelle is some kind of “Wonder Woman.” How else to describe her layered risk-management remediation plan that weathered three days, two audits, and two Notified Bodies. Love!

  • Peter Barthe
    President and CEO
    Ardent Sound

This little product went to market

I’m not worried about that little product at all.

It’s his sibling that concerns me. That little product stayed home.

It stayed home because it didn’t clearly demonstrate safety, efficacy, and compliance in its submission so regulators could let it out of its development house.

That little product should have called me.

Which submission approach?

“Which pathway?” is more of a check-all-that-apply type question.

There are likely multiple right answers. My job is to guide you to your very own best answer.

I’ve been told this handy 13-page guide is incredibly helpful, so start there and pick up your own copy now.

When complete, you’ll have a detailed analysis of submission options, costs, and timelines.

We can review all the potential options together:

For Medical Devices
• 510(k) – Traditional, Abbreviated, Special
• PMA
• De novo
• Pre-submission meetings, 513 (g), and more
• EU Technical File

For Combination Products
• Requests for Designations
• Support for submission type after designation (510(k), NDA, etc.)

For Biologics, the BLA

For Drugs
• HDEs and Orphan Drugs
• NDAs and ANDAs
• OTC
• Monograph

For Food and Dietary Supplements
• GRAS
• NDI

For Cosmetics, an ingredient assessment

Sound good?

If you’re afraid downloading the Regulatory Pathway Assessment is an invitation for me to sell you stuff, rest easily.

I’m blessed with plenty of business, and have the luxury of working only with people who want to work with me(!).

We’ll know pretty quickly if Lean and You make a formidable team.

So either way, go ahead and download your copy. It will illustrate questions you might not have known were even on the test!

+ Michelle +

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Michelle Lott helps clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. Her expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
Winning in the marketplace!

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