PET Drug & cGMP Training Services
We have worked hard to comply with FDA 21CFR Part 211 & 212. Our experience in filing drug applications with the FDA, receiving marketing approval, along with several FDA site inspections under our belt means we know and understand cGMP requirements. We have developed a comprehensive training program around PET drug manufacturing and cGMP compliance where attendees participate in both class-room and laboratory training to learn all things related to PET drug cGMP. Please contact us to learn more about our training programs.
PET Drug FDA Approval
Any company desiring to produce and distribute approved generic PET Drugs are now required to file a New Drug Application and wait for approval from the FDA before commencing producing and distributing for human use. Wisconsin Medical Cyclotron has been through this process and understands the time-consuming and costly nature of the process to succeed in obtaining FDA approval. We have several PET Drug manufacturing sites who via a licensing arrangement with us were able to reduce the time and cost required to get into human use Generic PET Drug manufacturing and distribution. Please contact us to learn more.
SPECT Pharmacy Design, Build, & Startup
Opening a SPECT Radiopharmacy involves a comprehensive well thought out set of tasks and project management. From design and layout considerations, to cleanroom and equipment selection, build-out steps, employee hiring & training, personnel and USP 797 validations, RAM licensing, supply and generator ordering, official startup tasks to grand opening we have not only successfully been through it all but have held training events to share what we learned during the process. Contact us to learn more.
Site Tours, Visits, and Learning Opportunities
We hear time again that our site contains technologies and processes of interest to those in health-care and nuclear medicine. We pride ourselves in telling our story, sharing our history, our accomplishments, and what sets us apart. We have hosted nuclear medicine departments from local hospital institutions, suppliers & vendors, students, and those interested in starting up PET/SPECT sites nationally and internationally for tours and learning events. We invite you to visit Wisconsin Medical Cyclotron and Radiopharmacy to learn all about what we do, how we do it including sharing information about the technologies we utilize. Please contact us for more information.