Life sciences, medical device and biotechnology companies are continuously looking into optimizing their regulatory submissions planning processes, while coping with increased workloads in order to support simultaneous global submissions and reducing time to market. At the same time, the breadth and depth of regulatory regimes are growing across most regulatory authorities, with increasing regulations and expectations. These drivers of complexity create intense demands on Regulatory Affairs teams, and require more meaningful ways of managing regulatory requirements, traditionally left to the devices of spreadsheets and checklists. The challenges encountered during downstream regulatory activities such as incomplete filings, significant last minute re-work, etc., are primarily due to lack of upfront understanding of regulatory requirements around regulatory activities and/or filings across the globe. Better approaches are required to increase efficiency, capacity and quality simultaneously around regulatory activities.
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