Isotope flexibility means we can work with any isotope, regardless of its complexity. However, nuclear medicine supply shortages—including isotopes—can delay radiopharmaceuticals from getting to market, potentially disrupting patient care. Our commitment to reliability means we ensure uninterrupted radiopharmaceutical supply and a transparent manufacturing process—minimizing costly delays and ensuring timely patient access.
Outcome
Outcome
Outcome
Fully isotope agnostic approach means we can work with any isotope for maximum flexibility in development and production. Because we have no competing products, our focus is on your supply chain success.
Custom-designed shipping package compliant to IATA 7A/Type A requirements for domestic and international shipping
Single-use and disposable GPS tracking technology powered by “Trackonomy,” which allows customers to see their shipment location in real-time by using our proprietary mobile app.
All our facilities are built to exceed compliance and our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.
Facilities built for operating under 21 CFR Part 211 with PA/AZ expansion sites also aligned to EU Annex 1. ISO 13408-6 Aseptic processing of health care products
Manufacturing and R&D facilities independently licensed for radioactive materials and transportation approvals for shipping hazardous materials. State of the Art Carbon Filtration System Compliant to USNRC Regulatory Guide 1.52 for residence time and volumetric airflow.
Corporate Quality Management System established and aligned to 21 CFR Part 211 and ICH Q10
Our commitment to reliability means we ensure uninterrupted radiopharmaceutical supply and a transparent manufacturing process.
Curious about how our CDMO services can help your organization? Contact our Business Development Team to discuss our capabilities.
Contact UsExplore our open radiopharmaceutical jobs in Rochester, MN and Pennsylvania facilities.
