Agnes Cwienczek, Head of Product Management and Consulting at Amplexor Life Sciences
Find out how companies can improve business agility by producing and managing compliant, high-quality submissions in a cost and time-efficient manner.
Submission Management & Publishing is a critical activity in Regulatory Operations with an ever-increasing need for cost and time efficiency while accommodating the flexibility to quickly react to changes or urgent submission needs. It became an essential part of the overall Regulatory Information Management process throughout the past years, instead of being an isolated domain in the operations space.
Many companies succeeded in establishing well-defined Submission Content Management & Publishing processes stretching from the global to the local organisation, including many processes and content contributors and consumers like the service providers supporting the company’s delivery needs. Recently, additional attention is being paid towards automation of routine tasks within and beyond Submission Content Management & Publishing activities to further improve efficiency and reduce human errors.