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
• 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
• HDEs and Orphan Drugs
• NDAs and ANDAs
For Food and Dietary Supplements
For Cosmetics, an ingredient assessment
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 +