Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Regulatory Submissions

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 us.

Which submission approach?

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

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

We’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.

Nobody has time for antiquated nonsense

Are you afraid I’ll put you on some big list and try to sell you all the time? Well, newsflash….
Nobody has time for that antiquated nonsense. You don’t. And I definitely don’t. So, if you’ve
got a question about regulatory strategy, just ask me already.

LET’S TALK

Why You Need A Strong Regulatory Strategy?

First, you’re going to do regulatory something anyway. It’s unavoidable. So if you’re doing it anyway, do
it smartly. With me, with someone else. But do it smartly and in the least burdensome way. Beat your
competition while you’re at it.

Second, a strong regulatory strategy lets you:

Get money

Investors like knowing what they’re investing in.

If you can’t effectively project costs, timelines, and testing, you ain’t getting the money. Sorry about that.

Skirt death

Come to Arizona, buy me a glass of wine, and I’ll tell you about the clients who should have called me sooner. Because when you get caught being out of compliance, you’re already in a ditch.

I can help you out of the ditch, sure. But you’ll need shovels to cover up that huge hole. Probably a landscaper too. All could have been avoided, just sayin’.

Expedite clearance

Without a strong regulatory strategy, your submissions risk getting sucked into a bureaucratic vortex. Oh, the time wasted going back and forth for a change here, an edit there.

It adds up and pushes your launch back further and further.

Michelle provided us with an excellent quality system plan. She’s knowledgeable, professional, and I enjoy her!

Jen Watson Koevary
COO, Avery Therapeutics

Jen Watson Koevary

Contents Of A Strong Regulatory Strategy

You’ll see. This isn’t so bad. And I can help you with each.

  • Clear intended use and indications statement.
  • Product type determination
  • Product code determination
  • Product classification
  • Identification of any exemptions
  • Itemization of applicable recognized consensus standards
  • Itemization of applicable FDA guidance documents
  • Analysis, costs, risks and recommendation for submission options
  • Analysis and recommendation for test strategies based on standards and guidance documents
  • Review of changing regulations, policies, or politics that may affect product clearance
  • Quality Management System requirements, costs, and resources post commercialization

Help Has Arrived!

Pick an open half hour on my calendar. Maybe I can lighten your workload and I would LOVE to help!

let’s connect!