Michel Moravia 0:00
I'm Michel, CEO of quality means business, and also co founder and CEO of qualivers, an AI first solution that solves the issue of US FDA. We have a broad team that brought this together, from mechanical engineers, AI engineers and ex FDA regulatory consultants. We breeded the minds, and this is definitely a competitive advantage of quality means business in flipping the script. We don't bill in terms of hours. We're project oriented, result oriented, and our AI platform has really transcended what was the typical we believe we will empower and democratize innovation for the future generation who should come and see me three times early. If you're starting a new project, you have a project in flight for a new product to bring to market. If you're ready to do a regulatory submission, we can look through your technical files and ensure that, hey, your odds of approval are quite high. And lastly, if you have an audit finding of any sort, especially around design controls, come and see us, and we'll make sure we accelerate the corrective actions and things of that nature, and we leverage our AI platform to collect all this information and move rather quickly. Our goal is to be performance oriented, results oriented, as opposed to billing time. We ensure we understand your pain points and we assess, what can we do to ensure that you get the best desired outcome? Our AI platform is quite novel, quite disruptive. It does three things. It automates the regulatory process, all that manual market research that you used to have to do, which would take calendar months. Now it's done leveraging generative AI, pretty much you get all that information in terms of your product code, your predicate device and your regulatory submission strategy, then we sort of automate the generation of all the technical documentation that the USFDA has to review based on your product and your desired market. And lastly, with our proprietary algorithm, we give you a risk score and telling you, are you ready to do a submission and where do you need to focus up the odds of ensuring success? It's all about the startups and innovation for us thinking that we can empower the startups to drive innovation by not letting FDA compliance or out in the EU be a bottleneck. They're great innovators. We want to empower them with a tool that gives them the regulatory quality muscle to really drive success for the organization. That's our goal. Who we typically really work with is the biopharma therapeutic players, predominantly combination products, drug device delivery systems such as infusion pumps, inhalers, asthma inhalers and things of that nature. And this is important to us because we believe it's the shift from small molecules to large molecules in terms of biologics and personalized medicine. So that's our sweet spot, and who we're really helping bring new products to markets faster and also de risking the process. Our predominant focus are the USA, Canada and Europe. So crossbreeding between those those three are our strong suit. MD SAP, in terms of harmonizing all of these regulations, ISO certified, is where we shine. You.
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