Year: 2021-22

Company: Ascendis Pharma

Liaison(s): Yvonne Coffey, Laura Smith, Anaia Davidson, Mary Wilhelm, Gary Kirk, Liam Curran

Ascendis Pharma is an innovative technology company that’s building to become a leading, fully integrated global biopharmaceutical company making significant differences to patient’s lives. The company was founded in 2007 and have established themselves in the industry through their innovative TransCon (transient conjugation) technology platform to meet unmet clinical needs for various populations. As with any leading pharmaceutical company, regulatory affairs are an integral part of day-to-day operations. Ascendis Pharma is interested in the reclassification of its Veeva Vault documents to increase overall accessibility and efficiency of the company. In order to accomplish this, the team was tasked with completing a careful analysis of Standard Operating Procedure trainings and the standardization of Veeva documents to deliver a recommendation for future document management. Through learning about the regulatory affairs of Ascendis, our team was able to assist in organizing these documents so as to increase the efficiency of future file requests. As we have become more familiar with various regulatory documents, we have moved into the analysis of different Health Authority questions and responses. Our team hopes to present our final results showing how these processes are critical for an efficient regulatory strategy team. We hope this work will allow the Regulatory Team at Ascendis to search and retrieve documents in a more efficient manner as they continue to grow and expand.