Michel Moravia 0:03
Good morning ladies and gentlemen. My name is Michel Moravia, CEO of Quality Means Business. That Quality Means Business, our team, we have a world class team that's growing. We have over 100 years of experience in the pharma and medtech industry, helping biopharma and med tech firms bring new products to market and hop over the hurdles of the US FDA, and other regulatory bodies around the world. We're fortunate to have a lot of key strategic partners. And what's most interesting about our firm is that we also have a software component. As the CEO and founder I've been fortunate to have worked for EA tq. Alliance compliance quest, well established enterprise software companies, we support from startups all the way to big strategic companies, such as ABS Z, pharmaceuticals, and bringing new products to market. Our passion at Quality Means Business focuses on what I call med Tech's biggest nightmare, US FDA denial, it takes a minimum invested time of two to six years to bring a product to market 24 million solely on FDA related activities. And here's the kicker, when all of this is said and done, the medical device manufacturers face an alarming 75% rejection rate for complex devices. Think of your infusion pumps, auto inhalers, and things of that nature. But even when you take a peek underneath the hood, what you see is it's not the innovation, it's not the science. It's actually the administrative side of things in terms of the paperwork to technical documentation, missing key information, not choosing the right predicate device, things of that nature. So that's a passion of ours and in a key area that we wish to solve. So for about a year now, we went back we thought about this, I've been fortunate to have brought over 12 products to market to combination products, drugs and devices to the FDA. So I created a team, and we went to work and we build the first AI powered software that solves the issue of US FDA denial. We do it three ways. Number one, we automate, we automate the process of all of that regulatory busy work in terms of finding the proper predicate device. It used to take calendar months now we have it down to a stopwatch. Next, we accelerate the generation of all of the technical documentation that the US FDA reviews using generative AI. And lastly, and most importantly, we have de risked the process with a conditional patent with a seven point parameter proprietary model that ensures that you're indeed ready. And this is supported by our ex FDA experts. Were we're not stopping here just with the software. We're looking to drive an ecosystem where we democratize innovation, and regulatory submission and overall regulatory strategy. So in the coming months, we look to launch our new podcast quality in the boardroom quality in the boardroom will give to the scientists, the innovators, the quality regulatory pros, the business acumen to talk the language of business and really center quality as an innovation and profit center.
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