Applicants dedicate a vast amount of time and effort to get their regulatory submissions in compliance with exchange standards (such as eCTD) in order to facilitate the review process by the Health Authorities with the ultimate goal of obtaining approvals. These applications contain a wealth of knowledge about the Medical Product and its Life Cycle and are therefore to be treated as a valuable asset for the company. With the help of Dossplorer™ these submissions can not only be used to transfer information to the Regulators, but also support numerous other business cases (e.g., regulatory impact assessment).
Traditional eCTD viewing tools are often limited to viewing single applications (a single product in a single country) at a time. Although this is how eCTD is currently handled by the regulators, this is not how companies manage their products internally. For example, a regulatory impact assessment is to be performed across various products and registrations. Dossplorer™ offers unique viewing capabilities beyond the traditional sequence/cumulative/current view. This enables users to create holistic views across multiple applications which supports fast and informed decision making.
Unfortunately, for the most part regulatory information is still trapped in ‘digitalised paper’ in the form of PDFs. To unlock this information Dossplorer™ offers full text indexing and advanced analytical capabilities.
This featured presentation will be led by Qdossier’s Director of Regulatory Information Management, Michiel Stam. Michiel will also be available after the presentation for a live Q/A session.
Qdossier, a Celegence Company, will be hosting the webinar on Wednesday, October 26th at 10:00 AM Eastern Time – Register online now!