Radio Pharma Consulting

Healthcare Services

AI Solutions

Radiation Safety & Licensing

Protecting people, products, and processes with regulatory precision.

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Radiation Safety Compliance Made Easy

SG BioSciences offers expert consulting in radiation safety and licensing, supporting facilities that handle radioactive materials in compliance with local and international standards. We implement robust safety frameworks and assist in obtaining the necessary authorizations to operate responsibly. 

Our Services

FDA, EMA, and NRC Compliance Strategy

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. 

GMP, GCP, and GLP Audit Readiness

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. 

ICH Guidelines & Radiation Safety Implementation

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. 

eCTD Filing for Radiopharma

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. 

Radiation Protection Planning

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. 

Dosimetry Calculations & Quality Control

Establishing dose monitoring systems and QA programs to ensure compliance and safety. Our consultants guide you in choosing the right systems to track radiation doses and maintain consistent quality checks. We help ensure everything is working properly and that your facility meets all required health and safety rules. 

Staff Training in Radiological Safety

Educating personnel on safe handling, emergency procedures, and regulatory responsibilities. We offer tailored training programs to help your staff understand radiation safety basics, proper handling methods, and what to do in case of emergencies. Our consulting services also cover your team’s legal responsibilities so they feel confident and prepared. 

Licensing Support

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. 

Contact Us

Need help improving radiation safety or navigating licensing? Our experts offer trusted consulting support to keep your operations compliant and safe. Reach out today to discuss your facility’s needs.