Facet Life Sciences Named Regulatory Partner for Nucleus Radiopharmaceuticals

• Facet Life Sciences has been appointed the official regulatory partner of Nucleus, a company specialising in diagnostic and therapeutic radiopharmaceuticals.

• Facet brings experience from over 40 FDA submissions and 75 agency meetings to support regulatory strategy and development.

Facet Life Sciences has announced its appointment as the official regulatory partner of Nucleus, a company developing diagnostic and therapeutic radiopharmaceuticals. The partnership will focus on providing support with US Food and Drug Administration (FDA) interactions, submissions, and strategic development.

The collaboration was announced as part of Facet’s expanded work in the radiopharmaceutical sector. “We are thrilled to join forces with Nucleus as their official regulatory partner,” said Ken VanLuvanee, President & CEO of Facet Life Sciences. “Our team brings extensive experience in regulatory strategy, medical writing, and regulatory submissions.”

Facet’s team has prepared and submitted over 40 regulatory applications to the FDA across IND, NDA, BLA, and ANDA pathways. In addition, the company has led more than 75 meetings with FDA divisions including CDER, CBER, and OGD. This experience underpins its offering of regulatory support to clients navigating drug development pathways.

Recognised by the FDA and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) as experts in radiopharmaceutical regulation, Facet is positioned to provide Nucleus and its clients with strategic insight and compliance support.