Radioactive Materials License Amendment Consulting
Remote nationwide support for qualifying changes to existing medical radioactive-materials licenses.
Remote nationwide RAM licensing support.
Available throughout the United States for existing licenses regulated by the NRC or an Agreement State.
Prepare for review: use the free medical RAM license amendment guide to organize the current license, proposed change, regulator, personnel, locations, procedures, and target date.
Changes that may require an amendment or another regulatory action.
The correct path depends on the license, jurisdiction, authorized use, personnel, and proposed change.
Materials and uses
Add a radionuclide, change possession limits, or add or change an authorized medical use.Rooms and locations
Add a treatment room, imaging location, or other authorized use area.Clinical programs
Adding nuclear-medicine, radiopharmaceutical therapy, or theranostics services.Procedures
Update radiation-safety procedures and supporting program documentation.Regulator coordination
Prepare supporting materials and respond to regulator questions within scope.A clear path from proposed change to implementation.
Inquiry and license review
Confirm the facility, authorization, jurisdiction, and planned change.
Path determination
Identify an amendment, notification, internal update, or new-license project.
Documentation and coordination
Prepare materials, address questions, and coordinate implementation.
Amendments versus completely new licenses.
Existing license with a proposed change
We review the authorization, identify the applicable path, and support qualifying amendment or facility-readiness work.
Ground-up new-license project
We refer ground-up applications to an experienced licensing partner and may support medical-physics and facility-readiness portions.
Medical RAM license amendment questions.
What is a RAM license amendment?
A radioactive-materials license amendment is a regulator-approved change to an existing license. Depending on the license and jurisdiction, a proposed change may instead require notification, internal documentation, or no formal amendment.
Do we need an amendment to add Pluvicto?
Not every Pluvicto project follows the same regulatory path. The facility's current authorization, radionuclides, uses, locations, personnel, procedures, and jurisdiction must be reviewed before determining whether an amendment is required.
Can you help add or remove a physician or Authorized User?
We can review and support qualifying requests to add or remove a physician or Authorized User from the licensed program or license, as applicable, subject to the jurisdiction, documentation, qualifications, and agreed scope. The licensee remains responsible for reviewing, approving, signing, and submitting the request.
Can you help amend our radioactive materials license so we can start a theranostics program?
Yes. We can review your existing radioactive materials license and planned theranostics service, then support qualifying amendment work for items such as Lu-177 therapies, Authorized Users or physicians, treatment locations, procedures, equipment, and radiation-safety documentation. The required path depends on the license, project scope, and NRC or Agreement State requirements.
Request a License Amendment Review
Free initial consultation and quote.
Not sure whether you need an amendment or a new license? Tell us what your facility is changing.
Email:
physicists@physicistsinradiology.com
Phone:
786-822-8383