FDA’s New Module 1 is a Bridge to eCTD 4 Blog Post

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a…

D360 Express Scientific Data Informatics Hub Blog Post

D360 Express is an out-of-the-box integrated solution specifically designed for discovery scientists at smaller pharmaceutical research organizations. It provides access, integration, analysis and visualization of scientific data from multiple data sources. D360 Express gets you up and running quickly and affordably.

The Role of a U.S. Agent Blog Post

Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the…

Rare Disease and Orphan Drug Development Blog Post

全球有 7,000 种罕见疾病困扰着 3.5 亿患者,但其中仅 300 种疾病拥有获批疗法。这一缺口影响了 95% 的罕见病患者群体,意味着巨大的未满足医疗需求。建模与模拟方法不仅是罕见病药物开发的理想工具,更获得监管机构的大力倡导。