Rho, a full-service CRO, has added a new Regulatory Strategy and Submissions business segment to support the planning, development and submission of 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 as the Chief Strategist. It will be supported by 35 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 Mr. 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 will work with clients on managing, integrating, analyzing, assessing and summarizing the data to support the approval of therapeutic products at all stages of development, from pre-IND through post-approval.