Regulatory Navigation

Ionetix experts Ensure You're Up & Running

The Food and Drug Administration must approve Site Registration for the licensed Abbreviated New Drug Application (ANDA) that is used for N-13 Ammonia drug production. Ionetix currently employs regulatory experts with previous experience with large commercial radiopharmaceutical vendors. Their experience in regulatory affairs pertaining to ANDA approval will ensure a timely approval.

Ionetix will register and manage all FDA production site requirements. We will obtain and manage all NRC or State radioactive materials licenses, or will assist the customer in amending their license to include the cyclotron production system. Ionetix will also file with the state for a radiation producing machine registration similar to CT or X-ray devices. In addition, Ionetix will provide staffing and service required to produce doses.