Executive Advisor, Quality and Regulatory
Dennis DeCola brings 35 years of experience in various leadership and management positions across established and start up Johnson and Johnson companies.
His diverse background includes Clinical Trial development programs, Quality Assurance, US and International Regulatory Affairs and class three medical device Product Development. Early in his career, Dennis was responsible for a portfolio of 300 510K/PMA devices and 2 NDA products. He also served on the leadership team that developed the strategy to advance an idea from early-stage research through product development and clinical trials, ultimately resulting in the formation of Therakos.
Post Johnson and Johnson, Dennis acted as a regulatory consultant and strategic advisor helping numerous companies achieve their goals. He worked on projects that included treatments for Duchene’s muscular dystrophy, a patented surgical drug/device combination product for closing periodontal disease pockets, a sublingual buprenorphine/naloxone treatment for opioid addiction, a new liquid formulation of Rilutek for ALS and other novel products.
In his role as Executive Advisor, Quality and Regulatory at Therakos, Dennis serves as a regulatory consultant and strategic advisor.