Regulatory Submissions, Information, and Document Management Forum
Regulatory information is arguably the most valuable asset of a pharmaceutical, biotech, or medical device company. It includes data, meta-data, documents, and other forms of information about regulatory and submission intelligence, regulatory authority submission and reporting requirements, submission plans for new products, and lifecycle management activities, as well as product registration information, labeling, CMC, safety submissions, communications from health authorities, and more. How regulatory information is managed has a profound impact on operational efficiency across the whole o...