SpectronRx is a CDMO that is FDA and EMA inspected.   We are licensed to handle multiple Therapeutic and Diagnostic isotopes pharmaceutical grade including Pb-212, Lu-177, Ac-225 and I-131 for various clinical applications.  Spectron operates under a quality program that has been inspected by the FDA with approved drugs FDG, NaF and Ammonia.  Spectron provides labeling and contract manufacturing services as it relates to Lu-177, Ac-225, I-131, I-124, I-111, Zr-89, Copper-64 and Fluorine-18.

Health Care

Nuclear

Pharmaceutical

SpectronRx

SpectronRx's headquarters in Indianapolis, IN, United States

John A. Zehner

Kelli Lightfoot

Anwer Rizvi

Peter Webner

Bill Monachino

Beth Kraemer Rph

The Quality Control Team at SpectronRx ensures the integrity and compliance of all pharmaceutical isotopes and radiolabeling products by conducting rigorous testing and analysis according to FDA and EMA standards. This includes validating manufacturing processes, performing environmental monitoring, and maintaining high standards for product safety and efficacy. The team plays a critical role in ensuring that all therapeutic and diagnostic isotopes meet stringent quality requirements before reaching clinical settings.

Quality Control Team

The Manufacturing and Production Team at SpectronRx is responsible for the production and quality control of pharmaceutical-grade therapeutic and diagnostic isotopes such as Pb-212, Lu-177, Ac-225, and I-131. This team ensures that all manufacturing processes comply with FDA and EMA regulations, manages the labeling and contract manufacturing services, and oversees the production of approved drugs like FDG, NaF, and Ammonia. Key roles include production chemists, specialists in radiopharmaceutical production, and nuclear pharmacists, all working together to maintain high standards of safety, efficiency, and regulatory compliance.

Manufacturing and Production Team

The Project Management Team at SpectronRx oversees the planning, coordination, and execution of various projects related to the labeling and contract manufacturing of therapeutic and diagnostic isotopes. They ensure project timelines and quality standards are met in adherence to FDA and EMA guidelines, while facilitating cross-functional collaboration to support research, development, and business growth objectives.

Project Management Team

The Research and Development (R&D) team at SpectronRx focuses on innovating and optimizing processes for the development and handling of therapeutic and diagnostic isotopes, such as Pb-212, Lu-177, Ac-225, and I-131. This team is responsible for advancing the company's capabilities in pharmaceutical grade isotope labeling and contract manufacturing, ensuring adherence to stringent FDA and EMA standards. Their work involves extensive experimentation, refining production methods, and collaborating closely with other departments to bring new radiopharmaceutical solutions from concept to clinical application.

Research and Development

The Engineering and IT Team at SpectronRx is responsible for the design, development, and maintenance of advanced pharmaceutical manufacturing systems and supporting infrastructure. This team ensures the seamless integration of cutting-edge technology in the production and labeling of therapeutic and diagnostic isotopes, optimizes operational workflows, manages IT infrastructure, and provides technical support to uphold the company's stringent quality and regulatory standards.

Engineering and IT Team

The Leadership Team at SpectronRx is responsible for setting the strategic direction and ensuring the operational excellence of the company. This team, comprising the CEO, Sr VP of Quality, Regulatory, and Technical Compliance, and the Chief Administrative Officer, oversees compliance with FDA and EMA regulations, drives business growth, maintains high-quality standards for isotope handling and pharmaceutical manufacturing, and ensures effective organizational administration. Their leadership is crucial for steering SpectronRx's mission to provide top-tier labeling and contract manufacturing services for therapeutic and diagnostic isotopes.

SpectronRx

Org chart

Teams

Quality Control Team

Manufacturing and Production Team

Project Management Team

Research and Development

Engineering and IT Team

Leadership Team

Offices

SpectronRx

Org chart

Teams

Quality Control Team

Manufacturing and Production Team

Project Management Team

Research and Development

Engineering and IT Team

Leadership Team

Offices

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