Integrated preclinical IND enabling program developed on tight timelines.

Early development support for lead selection.

Early toxicology work led to integrated program coupling chemical development, radio-labeled API preparation and cGMP scale-up to provide test article for metabolism study.

Process development and scale-up of a long and difficult process with low productivity.

Assist Client in solving API preparation problems, supply API and supporting GLP toxicology for IND.

Client asked Ricerca to develop a robust chemical process and complete GLP toxicology to support a major program and file an IND on a very aggressive timeline.