PHOENIXVILLE, Pa., May 29, 2025 /PRNewswire/ — Facet Life Sciences specializes in guiding life science companies through the complex journey of drug, biologic, and medical device development and registration with the US FDA. Facet is pleased to announce the company’s role as the official regulatory partner of Nucleus, a leader in the field of diagnostic and therapeutic radiopharmaceuticals. As a partner of Nucleus, Facet specializes in providing US regulatory and development support for diagnostic and therapeutic radiopharmaceuticals.
“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 to help life science companies navigate the complexities of FDA interactions. We are excited to apply our expertise in the radiopharmaceutical space and support Nucleus and their clients in advancing innovative products to and through FDA.”
Facet’s regulatory team has prepared and submitted over 40 radiopharm IND, NDA, BLA, and ANDA applications to FDA, leading more than 75 meetings with various FDA divisions, including CDER, CBER, and OGD. Facet is recognized by both the FDA and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) as an expert in the field of US regulatory affairs and diagnostic and therapeutic radiopharmaceuticals. Facet’s experience and knowledge position them as an ideal strategic partner for Nucleus, offering critical guidance to their clients for navigating FDA approval processes and ensuring the successful development of radiopharmaceutical products.
About Facet Life Sciences
Facet specializes in delivering tailored solutions to navigate FDA regulatory pathways across every stage of drug, biologic, and medical device development. With over 20 professionals, each with 15+ years of direct FDA experience, Facet delivers nimble, cost-effective, experience-driven strategies. Learn more at https://facetlifesciences.com/ and visit our specialty imaging agents page.
About Nucleus Radiopharma
Nucleus RadioPharma is an innovative CDMO dedicated to the development and manufacturing of targeted radiotherapies. With an emphasis on innovation and quality, Nucleus provides an array of services, from formulation and analytical development to regulatory documentation and drug product manufacturing. Its technology platforms are at the forefront of radiopharmaceutical research, designed to advance new therapies through clinical trials to commercialization. Learn more at https://nucleusrad.com/.
SOURCE Facet Life Sciences
