PHOENIXVILLE, PA — Facet Life Sciences, a firm specializing in regulatory guidance for life science companies, has announced its partnership with Nucleus, a leader in diagnostic and therapeutic radiopharmaceuticals. Facet will serve as Nucleus’ official regulatory partner, providing expertise in U.S. regulatory affairs and development support for innovative products in the radiopharmaceutical sector.
Ken VanLuvanee, President & CEO of Facet Life Sciences, emphasized the significance of this partnership. “We are thrilled to join forces with Nucleus as their official regulatory partner,” VanLuvanee stated. “Our team brings extensive experience in regulatory strategy, medical writing, and submissions to help life science companies manage the intricacies 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 possesses deep expertise, having prepared and submitted over 40 applications to the U.S. Food and Drug Administration (FDA) for Investigational New Drugs (IND), New Drug Applications (NDA), Biologics License Applications (BLA), and Abbreviated New Drug Applications (ANDA). The team has also led more than 75 FDA meetings involving various divisions, including the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Office of Generic Drugs (OGD).
Recognized by the FDA and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) as experts in diagnostic and therapeutic radiopharmaceuticals, Facet is well-positioned to provide Nucleus with critical guidance. Their regulatory approach will help ensure effective navigation of the FDA approval process and accelerate the development of radiopharmaceutical products.
This partnership spotlights Facet’s efforts to advance the development of life-saving therapies and reinforces Nucleus’ leadership in the radiopharmaceutical field. Together, the two organizations aim to drive innovation and bring cutting-edge medical advancements to market.
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