INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)

eutical manufacturing technologies. Please review the attached Intent to Sole Source FDA-75F40126Q00155 document for more information.

The FDA / Center for Drug Evaluation and Research (CDER) / Office of Pharmaceutical Quality Research (OPQR) requires to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmac