Contract Manufacturing

Contract Manufacturing

The Contract manufacturing of radiopharmaceuticals pursuant to cGMP, FDA and NRC guidelines is one our firm's core competencies.

Our facilities are state of the art and science with design and build out qualifications meeting and or exceeding those of much larger organizations.  The facility is designed for the production of radiopharmaceuticals with hazardous chemical or API's and or controlled substances.   Every effort has been taken into consideration to plan for the myriad of potential customer requests ranging from targeted cellular diagnostic to Investigational New Drug formulations.  Current capacity allows for the validation and production of IND Phase II through Pilot Plant Orphan Drug manufacture and distribution.  Opportunities capacity are available to expand scaled resources to dedicated and automated medium volume in line processes and production. 

We build quality into every aspect of the production of our products with particular emphasis on the Risk Based approach endorsed by the FDA's compliance division.  All process control IT infrastructure, environmental monitoring and control systems are validated in compliance with 21 CFR Part 11.  All environmental and process controls are validated to 21 CFR Part 11.  All sterile media fills for parenteral products are designed to be completed within our ISO 5 cGMP production lines utilizing barrier isolator technologies.   Automation in the form of radiopharmaceutical synthesis modules are designed to work within the barrier isolator technologies.