A global, top-tier pharmaceutical company required outsourcing support to manage a new drug application (NDA) submission—one of the largest ever filed with the U.S. Food and Drug Administration (FDA)—for its blood clotting and stroke reduction medicine. Accenture collaborated with the company over three years to manage the process end-to-end for the NDA.
Accenture augmented the client’s in-house resources, easing the impact of peak demand and providing both strategic and operational regulatory expertise to streamline the submission process. The team also implemented a regulatory information management platform to facilitate submission preparation and enhance communications with the client’s internal regulatory teams.
The massive submission encompassed more than 71,000 files, 66,000 PDF documents and 2,500 datasets. With Accenture’s help, the company completed the filing in compliance with eCTD standards in a timely manner and met its NDA submission goals.