Expedited Services Support an NDA Submission

A major pharmaceutical sponsor requested an antibody-targeted, chemotherapeutic drug assay to be further developed and validated under GLP. Their technically challenging compound required measurement in both its total and unconjugated forms using samples from ongoing global studies. As the NDA filing date was rapidly approaching, the sponsor needed us to validate samples and then analyze them quickly.

Scientists in our immunochemistry department successfully provided GLP validation of the two methods and conducted sample analyses within the required time frame. Our sample management coordinators developed an efficient sample identification system for this project and managed sample delivery from hospitals around the world. Working as a team, the PPD laboratory provided timely data to the sponsor resulting in a timely and successful NDA filing and approval.