Let’s Get Small
I named my company Lean because I believe smaller is better. And while quality systems aren’t one-size-fits-all, the leaner, the less burdensome, which is better for you and your governing bodies.
So “let’s get small” together and give you the quality management system (QMS) you need.
No more, no less.
Yay, my product is cleared. The hard part is done!
Alas, no. The contrary is true.
We’ve got to assess, implement, and maintain a compliant QMS – it’s a living, breathing, use-every-day system.
And once you’ve got “maintaining” under control, look over there! It’s a changing regulation!
No sweat. We’re buds now, so we can study the new regulations, guidance documents, and standards for you. Then, we’re ready to create transition and implementation plans on your behalf.
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.
Remediation to us is more than repairing quality system deficiencies.
It has to be.
We consider the underlying business system and company culture. That way, we can expedite resolution with the FDA, prevent recurrence, and improve your overall organizational health.
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:
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.
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’.
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’s Regulatory Pathway Assessment helped me get investment proposals, reliable cost estimates, and the confidence I was “doing everything right.”
Bill LearPresident, JULVIA
Have quality, will travel
All regulations are welcome here!
Whether you’re more of a ’21 CFR 820′ kinda guy or you dabble in the Eastern European and Health Canadian arts, we can MDR 2017/745, SOR 98-282, ISO 13485:2016, and MDSAP with the best of them.
So if you’re already there, or you’re ready to expand, so are we.