Video Transcription
Edwin Lindsay 00:02
Good afternoon, everybody. Compliance Solutions is based in three areas: the UK, Europe, and the US. We've got a team of 40 consultants, but we predominantly look at start-up, spin-out, small, early-stage companies because we understand the whole model of cash burn for companies. But also, all our consultants are not just consultants; they're hands-on consultants. They will actually help do the work. They will actually help educate your staff on how to do it. We've built a team, especially around companies, start-ups coming to us saying we don't want 5, 6, 7 different consultants in different areas, so we built a team of areas of expertise within our group that could cover nearly all medical devices, all aspects of medical devices, from cybersecurity, software, AI, biocompatibility, and sterilization. We've got a number of experts in there. We also act as US agents for people, for companies coming into the US, FDA importers. We have EU reps and UK reps to help bring companies into the UK and Europe, and we can represent you. But we also have a number of partnerships and collaborations with people, both in the UK and EU, but also predominantly in the US, to help companies come to the US. So we have a number of areas where we cover it, with regards to quality, regulatory, clinical, but we've also got a number of development partners. We've got a number of manufacturers, both for IVDs and for medical devices, that we can introduce, especially a lot of start-ups when they need some help. We also have a logistics arm to the business with regards to the US, where we can warehouse products, ship them to your customers, and deal with the customers for you. And then we have the business side of it, a number of associates that will help you with insurance, opening bank accounts, etc., so we pull in when required. We've tried to go for the one-stop shop for a lot of the SMEs, so they know exactly where to go. But we are actually building on this. So we've got a number of clinicians that we're working with in the US, ex-FDA clinicians, who we can then bring on to help you with the process. You see this is with partners. We've got Abington Health Group, who deal with IVD. They help with design and manufacturing. Bright Week, they deal with medical device design and manufacture. They've got six clean rooms and they control sterilization. We've got RAF Solutions based in Sunrise. They will act as a logistics warehousing for you. We've just brought on Dr. Jeremy Dublin, who's an FDA reviewer for clinical, but he's also ex-special forces. And then we've got Mike Kumas, who does a lot of the business risk for us, insurance for companies. Just a couple of examples of companies we've worked with; we've taken to the US. Some have actually helped right through to exit. Current Health, probably two years ago, had an exit with Best Buy for $460 million. We were involved from day one all the way through to exit with Best Buy. With Current Health, we acted as the quality regulatory department for six years. I was a VP of QRA from the outside looking in. From the inside looking out, we were CS Life Sciences, so we helped support start-ups in early stages to be their regulatory department, quality department, to help them where they don't have to bring in resources, one person to manage it all who might not know it all. Thank you. Applause.
