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SG BioSciences provides specialized consulting services for facilities handling radiolabeled compounds. Our solutions are designed to help you manage workflow, regulatory compliance, and quality standards in radiopharmaceutical preparation and imaging.
Custom compliance frameworks for U.S., EU, and nuclear regulatory authorities. Plans focus on understanding specific rules for each region, avoiding common errors, and preparing full documentation. It helps manufacturers stay inspection-ready and reduces the chances of delays or penalties.
Gap assessments, SOP development, and training to help you pass audits with confidence. We cover all areas auditors check, from process records to safety checks. Step-by-step guidance helps avoid mistakes, strengthen systems, and meet all quality and safety inspection points.
Integration of global safety standards, including radiation-specific protocols for radiopharma. Includes setting up safe handling practices, equipment checks, and reporting systems. Helps meet global health standards while keeping people safe in radioactive work environments.
Technical and scientific support for compiling and submitting radiopharma-specific eCTD modules. Our support covers file formatting, document tracking, and avoiding common submission errors. Makes the regulatory filing process easier and more organized for faster approvals.
Developing SOPs and safe-handling guidelines for the preparation, dispensing, and disposal of radiopharmaceuticals. We help teams create safe and clear step-by-step methods for dealing with radioactive drugs. From preparation to disposal, our solutions ensure everything is done correctly and safely to protect staff and patients.
Optimizing facility layout, shielding, and workflows for operational efficiency and radiation safety. We improve how rooms and equipment are arranged to keep things safe and organized. By making small changes to the setup, we help reduce risk, save time, and increase safety for people working with radioactive materials.
Implementing dose monitoring programs and secure, compliant tracking of isotope usage and stock levels. We set up systems that track how much radiation workers are exposed to and keep a close watch on isotope use. These programs help teams stay within safety limits and manage supplies better.
Providing regulatory, QA, and documentation support for PET/CT imaging centers and nuclear medicine units. We make sure imaging centers meet all the rules and have the right paperwork. From safety checks to regular updates, we help teams stay inspection-ready without adding extra burden.
Let us help you keep your radiopharma operations safe, efficient, and compliant. Reach out to learn how our focused solutions support your facility’s specialized needs.
We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected status.
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