Rho’s new business segment aims to streamline regulatory approval

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/wavebreakmedia)
(Image: Getty/wavebreakmedia)

Related tags: regulatory approval, regulatory, New drug application, New drug, Investigational new drug, Developmental biology

Rho will expand its services with the addition of its Regulatory Strategy and Submissions business segment.

The full-service contract research organization’s (CRO) new segment will support the company’s goal of helping sponsors plan, develop, and submit marketing applications including new drug applications​ (NDAs), biological license applications (BLAs), and marketing authorization applications (MAAs).

Rob Woolson, an applied statistician, will lead the segment as chief strategist with his experience in US and ex-US regulatory submissions. Woolson told us, “The new segment will help streamline our approach to regulatory submissions by providing an integrated approach that brings regulatory, clinical, non-clinical, CMC, and statistical experts together.”

Kevin Barber will join the segment as the vice president along with 35 staff members.

This new segment will add an integrated approach allowing, regulatory, clinical, nonclinical, and statistical experts to work side-by-side. The team will work to support the approval of therapeutic products and help clients at all stages of development from pre-investigational new drug (IND) through post-approval.

“Rho has a long history of successfully helping sponsors develop and submit marketing applications, and this change will help support our continued growth an excellence in this area,”​ said Woolson. 

Related news

Related products

show more

What do big pharma companies spend on R&D?

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 05-Nov-2018 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Related suppliers

Follow us

Products

View more

Webinars