Regulation & Quality
At Isotopia, our Regulation & Quality functions seamlessly integrate regulatory affairs and quality assurance to ensure full compliance with cGMP, ICH Q10, GPP, GDP, and ISO 9001:2015.
We provide tailored regulatory and quality support to our Aseptic Plant, Therapy Unit, and Radiopharmacy. Our systems are independently inspected by the Israeli Ministry of Health, U.S. FDA, the Standards Institution of Israel, and audited periodically by customers.
A robust QMS underpins our operation—from supplier qualification to audit cycles, documentation control, CAPA, and customer complaint resolution.
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.
- assessmentsOngoing staff training and regulatory updates.
- Digital tools to streamline compliance, real-time monitoring, and audit readiness.
Isotopia’s Regulatory & Quality Departments underpins each production unit, ensuring regulatory and quality excellence, radiation safety leadership, and unwavering customer commitment—delivering high-performance radiopharmaceuticals and sterile products with integrity and precision
