In the fast-paced world of pharmaceuticals, the digital revolution (hyperlink 1) has significantly impacted various aspects of the pharmaceutical industry, including regulatory affairs. As the pharma sector becomes increasingly complex(Hyperlink 2), the adoption of digital technologies has an important impact on the way regulatory affairs professionals operate (hyperlink 3).
Digital landscape (#eCTD, #digital, #gateway, #digital process; #real-time information)Electronic Common Technical Documents (eCTD) and electronic submission gateways have become the norm, leading to faster and more efficient regulatory submissions, but a new step has entered the digitalization process that has revolutionized regulatory processes in the pharmaceutical industry. The main aspects of digitalization processes in which manner the documents are managed have a direct impact on data collection and submission processes, reducing the likelihood of errors and expediting approval timelines.
Indeed, regulatory affairs professionals can access real-time information, allowing them to make data-driven decisions. This enables them to identify potential risks early, respond to changing regulations swiftly, and proactively address compliance issues.