
NorthStar Medical Technologies is partnering with Quarkmed, a Beijing-based contract research organization (CRO) specializing in nuclear medicine and radiopharmaceutical clinical development, the company announced today.
According to a release, Quarkmed will serve as NorthStar’s Registration Agent in China, enabling pharmaceutical and biotechnology companies worldwide to use NorthStar’s n.c.a. Ac-225 in Investigational New Drug (IND) applications submitted to China’s Center for Drug Evaluation (CDE).
“The future of radiopharmaceutical development is increasingly global,” NorthStar President and CEO Dr. Frank Scholz said in a statement. “By combining NorthStar’s proven U.S.-based Ac-225 manufacturing capabilities with Quarkmed’s regulatory expertise and local market presence, we can help radiopharmaceutical developers worldwide advance clinical programs in China as part of their broader commercialization plans.”
Also included in the partnership is that customers will gain access to translated, electronic Common Technical Document (eCTD)-compliant regulatory documentation to support IND submission in China.
