Building Partnerships for Client Advantage

A client’s first NDA was in jeopardy due to a failed pre-approval inspection of the contract lab conducting its stability testing. The stability study, transferred to PPD for the balance of the project, successfully passed cGMP audit by the FDA. PPD now handles stability programs, method development and validation projects for all compounds in this client’s pipeline. A full-time equivalent (FTE) agreement for more than 20 analysts dedicated to their projects assures them of a reliable analytical service partner who understands their needs.