Theranostics Development & Manufacturing Solutions

21 CFR 211 Manufacturing

PharmaLogic’s full service CDMO offerings and radiopharmacy solutions extend beyond diagnostics into therapeutic radiopharmaceutical development and manufacturing under 21 CFR 211 guidelines. With significant industry expertise, extensive network of cGMP manufacturing spaces, and a proven track record of logistics management, we are an ideal partner for your candidate.

Full Service CDMO

Leverage our network of experts to bring your therapeutic candidate from preclinical development through commercial launch with our comprehensive CDMO program.

cGMP Manufacturing

We support regional manufacturing and the distribution of shorter shelf-life radiotherapeutics and companion diagnostics across the country.

Industry-Recognized Regulatory Expertise

Specialized staff with more than 50 years combined expertise in industry, proven track record of significant milestone achievements in regulatory filings, and 21 CFR 211-specific experience.

Customized Partnerships

Fully customizable solutions and manufacturing process development that fits the needs of innovative radiopharmaceutical candidates.

Redundancy

With a focus on reliability, we have integrated redundancies throughout multiple centralized facilities under 21 CFR 211 manufacturing.

Integrated Distribution Solutions

With one of the largest radiopharmacy distribution networks in the industry, our robust in-house logistics infrastructure ensures efficiency for our clients via traditional ground transport and air-shipments.

Our philosophy of Trusted Quality Care is ingrained within each facility we design and operate. This allows for not only compliant production, but broader patient access to the latest advances in care. A core component of our mission is to bring the power of radiopharmaceuticals to as many patients as possible.