Quality & Regulatory

Excellence in radiopharmaceutical quality assurance minimizes disruptions

With all of Nucleus RadioPharma’s manufacturing facilities built to meet 21 CFR Part 211 manufacturing standards, our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.

Leverage first-hand expertise in quality control of radiopharmaceuticals

Radiopharmaceutical quality control requires specialized expertise, as diagnostics and radiotherapies have distinct regulatory and safety challenges. Our team ensures rigorous quality oversight to prevent disruptions, protect patient safety, and maintain compliance at every stage.

Outcome

– cGMP-compliant facilities designed to meet evolving FDA, NRC, and USDOT standards.
– Comprehensive quality control oversight from R&D through commercial production to ensure consistency and safety.

Outcome

– QMS real-time monitoring for proactive compliance management.
– Audit-ready documentation with detailed reporting and tracking.

Why choose Nucleus for your quality assurance and regulatory needs?

Dedicated R&D space, separate from manufacturing, to optimize quality before full-scale production. Compliance that goes beyond industry standards for seamless regulatory approvals, audit readiness, and risk mitigation.

~ 450K combined

product vials/year at full capacity in PA expansion site

Quality Assurance and Regulatory Compliance

All our facilities are built to exceed compliance and our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.

cGMP environment

Facilities built for operating under 21 CFR 211 with PA expansion site also aligned to EU Annex 1. ISO 13408-6 Aseptic processing of health care products.

Radiation safety program

Manufacturing and R&D facilities independently licensed for radioactive materials and transportation approvals for shipping hazardous materials. State of the Art Carbon Filtration System Compliant to USNRC Regulatory Guide 1.52 for residence time and volumetric airflow.

Electronic QMS

Corporate Quality Management System established and aligned to 21 CFR 211 and ICH Q10.

Quality & Regulatory FAQs

Leverage first-hand expertise in quality control of radiopharmaceuticals

Radiopharmaceuticals present unique demands across manufacturing, analytics, and regulatory alignment. Key difficulties include:

– Isotope decay and tight timelines. Radiolabeling, purification, QC, and formulation must all be synchronized within a limited window of radionuclide stability.

– Complex radiochemistry and purity demands. Achieving high radiochemical purity, specific activity, and minimizing metallic or chemical impurities is nontrivial.

– Safety, shielding, and facility constraints. Manufacturing must occur within properly designed, shielded hot cells or isolators under strict controls to prevent contamination and stray radiation consistent with 21 CFR 211.

– Analytical sensitivity and validation. QC assays must detect trace impurities, confirm radionuclidic and chemical purity, residual solvents, and stability—often under low activity levels.

– Supply chain fragility. Key isotopes and reagents are sourced from a limited supplier base and subject to regulatory, transport, and import/export restrictions.

From the earliest stages, design radiochemistry and purification methods that are scalable and reproducible. Analytical methods should be developed and qualified early, rather than fully validated, in accordance with phase-appropriate FDA expectations.

A comprehensive structured risk analysis, such as a Failure Modes and Effects Analysis (FMEA), should precede scale-up. Having a Supply Chain Redundancy and Backup Strategy as even the most robust process can fail if the supply chain falters. Transitioning from development to GMP readiness is a common choke point.

The more accurately you replicate the final production environment in advance, the fewer unexpected issues will arise during GMP manufacturing. CDMO involvement must extend into regulatory alignment.

Before IND submission, confirm the following readiness factors:

– Optimized and qualified radiolabeling/purification process

– Validated analytical methods with stability data

– Documented risk assessment and control strategy

– Redundant supply chains for critical reagents

– Engineering / mock GMP batches completed

– CMC documentation package (SOPs, validation reports, method transfer)

– Regulatory alignment via pre-IND meeting completed or scheduled