This expertise is coupled with our team's clinical experience and interaction with the U.S. Food and Drug Administration (FDA), as well as with other regulators around the world. Astrogenetix employs a rigorous set of standards and methodologies for experimental protocol design that will assure that microgravity processing will not only be understood by the regulating bodies, but also become the gold standard for processing pharmaceutical research in space.
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Astrogenetix offers design programs that allow pharmaceutical customers access to data generated from microgravity protocols during the discovery and pre-clinical phases of drug development. Building on our comprehensive internal programs, this means unprecedented access to the microgravity environment for a host of potential commercial customers.
Astrogenetix also provides pre-flight project design, on-orbit processing, final post-flight analysis, sample processing and data analysis.
In addition, the company provides data and other information about the composition of new drug entities (NDEs), their safety profiles, formulations, and how they will be administered to the first human subjects.