Kaleidoscope Innovation announced today that the regulatory, quality and clinical affairs consulting group, Regulatory Mark, is now part of the team at Kaleidoscope Innovation, an Infosys company specializing in the full spectrum of product design and development.
Led by regulatory industry veterans Alison Sathe and Colleen Murphy, the Regulatory Mark team will work closely with Elliott Fegelman, MD, Kaleidoscope’s Chief Medical Officer and VP of Medical Affairs, to expand and streamline the design consultancy’s regulatory strategy, licensing and support services. This includes leading FDA and EU MDR regulatory submissions for global regulatory licensing and ongoing compliance.
According to Fegelman, this formal partnership was a natural progression in an already strong working relationship between Kaleidoscope and Regulatory Mark. Since 2016, Kaleidoscope Innovation and Regulatory Mark have completed approximately 40 joint regulatory submission projects for medical device clients—all of which received regulatory clearance.
As the regulatory affairs market grows exponentially, Kaleidoscope projects they will triple the volume of packages they will submit for US and global EU clearance during the next two years.
“This merger allows us to offer a true total product lifecycle (TPLC) approach and integrate seamlessly with Kaleidoscope’s existing best-in-class processes,” Sathe and Murphy explained. “From regulatory strategy and planning at the concept stage through design and development and into post-market we can share insights to ensure efficient regulatory submissions and ongoing compliance.”
“The joining of these leadership teams and capabilities will allow us to offer our medical device clients—and ultimately the patients they serve—even more comprehensive and efficient services,” Fegelman explained. “We’re augmenting what’s already there—now with in-house, end-to-end capabilities.”
