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Chapel Hill, NC (December 10, 2018) – Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, today announced a new Regulatory Strategy and Submissions business segment. The segment will support Rho’s continued growth and excellence in helping sponsors plan, develop and submit marketing applications, including new drug applications (NDAs), biological license applications (BLAs) and marketing authorization applications (MAAs).
Rob Woolson, MS, JD, an applied statistician with an extensive background in statistical and project leadership working on US and ex-US regulatory submissions, will lead the new segment for Rho as the Chief Strategist. It will be supported by 35 highly experienced staff including new hire Dr. Kevin Barber, Vice President, Regulatory Strategy and Submissions, who brings more than 20 years of experience in regulatory affairs and product development across all stages of development.
“Rho has been successfully helping sponsors with marketing applications for decades,” said Woolson. “By dedicating a new business segment to regulatory strategy, we are positioned to expand our capabilities, capacity and expertise in the area, which will allow us to better serve our customers.”
The Regulatory Strategy and Submissions business segment provides an integrated approach, allowing regulatory, clinical, nonclinical, CMC and statistical experts to work side-by-side. Teams responsible for managing, integrating, analyzing, assessing and summarizing the data to support the approval of therapeutic products will work closely together to help clients at all stages of development, from pre-IND through post-approval.
For more information about the Regulatory Strategy and Submissions segment, visit www.rhoworld.com.
Rho, a privately-held, full-service contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.