Indianapolis, Indiana, United States
I am a partner in SpectronRx which is a Radiopharmaceutical CMO/CDMO/Isotope manufacturer that has been FDA inspected on behalf of the EMA. SpectronRx has over 220 employees. We offer services from Bench to Bedside. We can assist with NRC, FDA and EMA filings. We can improve product formulations. We manufacture Ac-225, Cu-64,F-18, Ga-68. Our team has managed the installation of several <19 MeV cyclotrons and two 70 MeV cyclotron from as "Green field" projects. I am a recipient of the 2020 Eaton Entrepreneurial award and the 2023 Distinguished Alumni award from the Purdue College of Pharmacy.
Spectron provides GMP grade Lu-177, Ac-225, I-131 and F-18. We offer Contract Manufacturing Services with Therapeutic and Diagnostic isotopes.
NukeMe provides regulatory support and business strategy for various clients associated with Nuclear Medicine. NukeMed has assisted with multiple PET cyclotrons from install to start-up to achieving FDA approval to daily operations with sales and marketing.
PET drug FDA manufacturing company that enables imaging providers to offer both unique and basic PET drugs such as F18 based products, N13 Ammonia and C11 products. We can provide access to ANDA's for FDG, NaF and Ammonia, as well as, provide IND's for other products.
Cyclotron, Pharmacy, Radiopharmaceutical and FDA