Author Archives: Karl-Heinz Loebel

From PDFs to Digital Submissions The Rapid Pace of Regulatory Change

The pace of regulatory change in the pharmaceutical industry over the past 20 years has been rapid. Although heightened emphasis on patient safety, data transparency, and harmonization has prompted new guidance’s and requirements, perhaps what is most notable is the rate at which technology has changed how processes are documented and regulated. Today, digitization is entrenched in day-to-day life and is steadily becoming the norm among health authorities and at pharmaceutical companies. But just two decades ago, incorporating technology-led regulatory…