Company Profile
A Global Leader in Innovative Radiopharmaceuticals for Diagnostics and Therapy
At Isotopia, we’re driven by a passion for pioneering excellence in radiopharmaceuticals to revolutionize patient care and advance the future of healthcare.
Since 2007, our unwavering focus has been on developing, manufacturing, and delivering cutting-edge diagnostic and therapeutic solutions in nuclear medicine that improve patient outcomes and quality of life.
Our Vision
To be the global leader in transforming nuclear medicine through pioneering research, advanced manufacturing, and compassionate patient care.
Our Focus
Our Global Operations
Israel
We specialize in the preparation, production, and quality control of ready-to-use PET and SPECT radiotracers, which enhance diagnostic accuracy and imaging quality.
United States
Designed for scalable GMP manufacturing, the facility features advanced production infrastructure, stringent quality systems, and pharmaceutical-grade processes that support both clinical and commercial radiopharmaceutical programs.
Working in parallel with our Israeli manufacturing site, it strengthens our global manufacturing capabilities and supply continuity, helping ensure uninterrupted delivery to customers worldwide.
Looking Forward – Our Commitment to Patients
Isotopia is committed to expanding access to our life-saving products worldwide.
We are actively pursuing marketing authorizations in multiple countries to bring hope to patients facing challenging medical conditions.
Isotopia is dedicated to working closely with healthcare providers, regulators, and the patient community worldwide to ensure that our products are accessible to all who can benefit from them.
Our Management Team
Our management team consists of passionate visionaries and pioneers in the field of radiopharmaceuticals. With a unique multidisciplinary blend of expertise and experience in the field, we are united behind a shared mission: to empower healthcare providers to diagnose and treat cancer with greater precision, efficacy, and safety.
Meet the leaders who bring their knowledge, dedication, and heart to the workplace every day, striving to provide hope and improve the lives of cancer patients facing this challenge.
Isotopia Management
Aseptic Plant- Israel
Radiopharmacy unit
Medical Advisor
Regulation & Quality
At Isotopia, our Regulatory & Quality functions integrate regulatory affairs and quality assurance to ensure compliance with cGMP, ICH Q10, GPP, GDP, and ISO 9001:2015.
We provide dedicated regulatory and quality support across our Aseptic Manufacturing, Therapy, and Radiopharmacy operations.
Our quality systems are independently inspected by the Israeli Ministry of Health, the U.S. FDA, the Standards Institution of Israel, and are regularly audited by customers.
A robust Quality Management System (QMS) supports every stage of our operations -from supplier qualification and documentation control to CAPA management, audits, and customer feedback.
Aseptic Plant
- Fully GMP-certified under both US FDA and Israeli MoH mutual recognition agreement with the European Union.
- Validated sterile production environment with continuous environmental monitoring for both lyophilized products and liquid fillings.
- End-to-end batch traceability, deviation handling and CAPA, supported by a validated computerized QMS and documentation system.
Therapy Unit
- Fully GMP-certified under the Israeli MoH mutual recognition agreement with the European Union.
- Specialized in clinical-grade therapeutic radiopharmaceutical production.
- Strict adherence to pharmacopoeias and cGMP guidelines covering raw materials, compounding, labeling, stability, transport, and storage controls.
- Ongoing regulatory inspections combined with customer feedback integration and satisfaction tracking.
- High-sensitivity QC (e.g. radionuclidic purity, sterility, radiochemical identity) and real-time monitoring.
Radiopharmacy
- Comprehensive lifecycle oversight: preparation → dispensing → transport → disposal
- Compliance throughout aligned with GPP regulations and ISO 9001 standards
- Comprehensive documentation, staff compliance, and training to maintain best practices
Radiation Safety
At Isotopia, regulatory radiation safety is upheld through a comprehensive Radiation Protection Program led by certified experts in protection, dosimetry, and compliance.
We apply engineering controls, shielding, and automated dispensing to reduce exposure to radiation.
Our experts oversee safety systems, monitor exposure data, conduct regular audits, and provide specialized training to ensure full compliance with IAEA, ICRP, and local regulations.
Continuous Improvement & Customer Focus
We strive not only to meet standards but to exceed them.
Our continuous improvement culture includes:
- Regular management reviews and risk-based assessments.
- Ongoing staff training and regulatory updates.
- Digital tools to streamline compliance, real-time monitoring, and audit readiness.
The certifications below reflect this commitment.
Our values
Our values shape our organizational culture and guide us in the choices we make, the services we offer and the partnerships we foster.
We strive to demonstrate these values in our actions and commitments, within the organization and our community.
Innovation and Growth Mindset
We embrace innovation and growth by constantly seeking dynamic, rigorous solutions in radiopharmaceuticals to enhance patient care.
Our culture values creativity, and new challenges and ideas, driving us to lead the field in advanced technologies that make a meaningful impact on people's lives.
Integrity and Professionalism
At Isotopia, we collaborate to achieve our shared business goals, fostering a culture of teamwork and individual accountability.
Through continuous encouragement, recognition of achievements, and mutual respect, we build team spirit and ensure consistent excellence in everything we do.
Empowerment and Ethics
We empower each other through ethical conduct, teamwork, fairness, mutual respect, and unwavering trust and reliability in all our interactions. We are committed to transparency, personal growth, and taking responsibility for our actions, ensuring we contribute positively to both our team and the communities we serve.
Effective Communication
We prioritize clear, transparent, and open communication, active listening and sharing of ideas, knowledge and feedback. By fostering collaboration and offering constructive feedback, we ensure seamless interactions at all levels of the organization.
Health, Safety, and Quality
We prioritize health, safety, and quality by strictly adhering to GMP and GPP standards, striving for excellence in every aspect of the process, every step of the way. Our commitment extends to continuous improvement, employee well-being, and environmental sustainability, while managing risks to ensure a safe and healthy work environment for all.
Service Excellence
Our service excellence is evident as we place patients first, focus on customer success and satisfaction, and consistently aim to exceed expectations with a strong customer-centered approach.