(908) 460-5648
SG BioSciences supports efficient clinical trial operations tailored to the unique requirements of radiolabeled compounds. We provide expert guidance from site readiness through protocol development to help you deliver compliant, safe, and effective clinical studies.
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.
Applying the ALARA (As Low As Reasonably Achievable) principle to minimize radiation exposure risk. We help you design safe environments and work processes to keep radiation exposure as low as possible. This includes reviewing current practices, setting clear safety goals, and offering expert advice to reduce exposure risks for patients, workers, and the public.
Evaluating and preparing clinical sites for radioactive handling, equipment compliance, and protocol suitability. This includes reviewing facility readiness, ensuring staff are trained, and confirming the site’s ability to follow safety guidelines and regulatory requirements.
Developing study protocols specifically tailored to the safety and regulatory needs of radiopharmaceuticals. We ensure each protocol fits the drug’s unique behavior, dosage details, and monitoring requirements while supporting trial success and patient safety.
Assisting with NRC, state, and international licensing applications and renewals. We support your team through every step of radiation-related licensing, including applications, renewals, and regulatory reviews. Whether it’s state, federal (NRC), or international compliance, we simplify the paperwork and requirements through expert consulting support.
Ready to strengthen your radiopharmaceutical trial from the ground up? Contact us to explore tailored solutions that align clinical operations with regulatory needs and sponsor expectations.
We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected status.
© 2026 SG BioSciences