Tech Transfer, Optimization and Validation
CTA/IND Filing & Amendments Experienced with FDA and EMA
Automation, Operational Improvements and Efficient Logistics
Radiance is a proven expert in contract development and manufacturing (CDMO) with a variety of isotopes. We are your experienced early-stage commercialization contract developer with a globally and nationally recognized reach in radiation therapy. Our teams provide the excellence you need to quickly achieve key milestones and drive demand for early-stage therapeutic and diagnostic development services. Radiance can be your end-to-end solution for all critical phases of drug development and roll-out to market, with the agility to customize execution based on your budget and timeline.
Radiance provides the necessary custom synthesis services to ensure consistency between batches. The radioconjugate is optimized, and procedures are defined for manufacturing and testing the potential radiopharmaceutical.
Whether the knowledge and tools for handling radiopharmaceutical products have been completely lost or whether a manual process needs to be automated to ensure readiness to scale, our team will tailor the deliverables to meet your end objectives.
All results are accurately documented in a detailed report, which can then serve as the basis for subsequent development and clinical phases, including the approval of a radiopharmaceutical.
We also offer product release, stability programs, and packaging to ensure a seamless transition to clinical and commercial production.
Hot cells, radiosynthesis, quality control and other equipment are integrated into our clean rooms according to customer requirements. Each laboratory used for radiopharmaceutical services is operated according to GLP and cGMP standards. Our experts are consulted to ensure the best environment for your needs.
Radiance serves as the Contract Manufacturing Organization (CMO) for products used in alpha, beta, or gamma radiation projects for both commercial and therapeutic use. No matter what type of radionuclides you need - dedicated radionuclides of the highest quality, radiolabeled drugs, or medical device manufacturing - our team can provide the best solutions tailored to your pre-determined requirements. As part of our services, we can also provide regulatory support; such as manufacturing license applications, and we share our knowledge of registration procedures to get you ready for your next step!
Our experience and capacity in clinical scale manufacturing for Phases I, II and III, up-to-date production facilities and extensive knowledge of radiopharmaceuticals make us your ideal partner for contract manufacturing in clinical phases. Each of our manufacturing facilities is set up to comply with GLP and cGMP regulations.
Clinical trials for radiopharmaceuticals run the risk of being delayed due to a variety of potential issues stemming from the complexity of regulatory requirements in each country. After all, progress involves developing new medical agents and coping with the new regulations required to move these radioactive isotopes across borders. Radiance can conduct a full clinical trial for new therapeutic or diagnostic agents at a partner radiology center. The service can provide clinical trial phases I/ II and II
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It can be very interesting if you pay us a visit, meet our team and see everything in action.
HCC Building, New Cairo, Egypt
+201001106920