Specializing in Regulatory Consulting, from Zero to full FDA approval. We are your partners for the life and evolution of your drug.
Anytime, any place, at any temperature, our expertise gets your drug delivered on time – whether through our strong global supplier network or our own services.
Monoclonal Antibody Labeling
Expertise in monoclonal labeling with a variety of isotopes and global reach in Radiotherapy. Multiple PhDs specializing in radiochemistry.
Proven Team of Experts.
We are proven experts in monoclonal antibody labeling, with a variety of isotopes. We are a Logistics champion of import/export, and a top-tier expert in world procurement of isotopes.
A Proven History of Success.
We are your experienced early-stage to commercialization contract developer with a global and domestic respected outreach in radiotherapy. The varied and experienced SpectronRx teams bring you the excellence needed for rapid advancement towards key milestones and Increased demand for early phase therapeutic and diagnostic development services. SpectronRx can be your END-to-END solution for ALL critical phases of drug development, now or scalable to your budget and timeline.
Your radiotherapyand isotope needs receive our white-glove concierge treatment. Our expertise is grounded in years of work in antibody labeling, isotope procurement and management, world logistics, regulatory strategies and more.
Monoclonal Antibody Labeling
SpectronRx can provide you with numerous solutions for radiolabeling of molecules and chemical entities. Labeling is frequently used as a modality to monitor the location or biodistribution of a molecule.
Anytime, any place, at any temperature, our engineered cold chain of custody science adapts to your patient’s targeted drug science for safe, effective, on-time deliveries at any phase of your drug discovery.
You have access to multiple PhDs and top-tier experts, managing your process and paperwork all the way to full FDA approval (including the holding of an IND). Proven experience in Regulatory Consulting, FDA Filings, Facilities Design and more.
Why choose SpectronRx?
You are in good hands with our “white glove” expertise, facilities, and depth of our isotope knowledge – nurturing your drug’s lifecycle needs through the entire process, through delivery and beyond. We are your resource for labeling, logistics and regulatory services, as well as radiotherapy engineering and consultation.
Here’s some highlights WHY you should work with us:
Advanced expertise in therapeutics with alpha/beta radiopharmaceuticals.
Strategic business acumen for tech transfer, scale-up, radionuclide timelines and logistics.
Wide range of isotopes, including Ac-225, Pb-212, Lu-177, I-123/131, Ge-68, Ga-68, Sr-82, Cu-64/67, In-111, F-18. Production Bunker Hill cyclotron 16MeV-70MeV.
3 CDMO facilities with multiple cleanrooms, and room for your expansions. Danbury, CT, opening, west coast expansion planned.
Experience with international requirements, shipping, temperature control and chain of custody telemetry monitoring of your drug.
Centrally located in the US, we have logistics capabilities and close proximity to major treatment centers and international hubs.
Advanced QC analytical support, analytical method validation, manufacturing process validation, and routine clinical supply.
Exceptional leadership, including John Zehner CEO, R.Ph., and Anwer Rizvi, President, who have combined 65+ years in medical isotope leadership positions.