Regenerative Outcomes
Biotechnology ResearchTennessee, United States2-10 Employees
Regenerative Outcomes came to fruition from an opportunity provided by its predecessor, the Regenerative Outcomes Foundation, a non-profit organization. Founder, Doug Oliver, is a Regenerative Medicine patient advocate, and created the foundation after receiving a miraculous stem cell treatment that restored his sight from being legally blind. Regenerative Outcomes provides highly specialized consulting services to small biotech’s and cellular therapy providers. We specialize in regulatory affairs and compliance consulting, with a primary focus on regulatory services to ensure clients achieve the coveted RMAT designation, a new, expedited pathway that the FDA and Doug Oliver created for regenerative medicine. This new designation allows for an IND (Investigational New Drug) to potentially reach market approval in as quickly as two years, while permitting innovators to simultaneously conclude phase three of their clinical trial. In the near future, some of our clients will literally change the face of healthcare and the world after achieving the RMAT designation - followed by widespread market approval of their innovation. This is the flagship service we provide, and with the exception of regulatory departments in large healthcare corporations, we are poised to be the only boutique firm in the country dedicated to this mission and niche regulatory service. Competitive efforts would fall short of having our founder’s expertise and insight to bring these life changing innovations to market. Doug Oliver literally helped to write the law and has key connections in the arenas of: capital, politics, specialized regulatory affairs, social policy, and medical social work. Doug’s work in crafting the 21st Century Cures Act, which made RMAT possible, also provided billions of dollars to the States to fund programs to address the Opioid crisis, another of our inter-related missions.
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