Pharmacovigilance and drug safety software is a vital tool that addresses manual data entry errors and manages the huge volume of safety data, among various other challenges. From clinical trials to post-marketing surveillance, this software is indispensable throughout the drug development lifecycle. Pharmacovigilance and drug safety software helps reduce adverse event processing time and improve patient safety through early signal detection. As regulations evolve and collaboration between European companies intensifies, the adoption of pharmacovigilance and drug safety software will become imperative for pharmaceutical companies and regulatory bodies. In 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) updated its guidelines on pharmacovigilance to adhere to international standards, highlighting the importance of robust pharmacovigilance and drug safety software. Also, in March 2024, The US Food and Drug Administration (FDA) provided guidance specifying the submission of investigational new drug (IND) safety reports for severe and suspected adverse events related to pharma drugs. These reports are submitted in electronic common technical document (eCTD) formats using PDF files. Further, the software ensures compliance with regulatory standards by facilitating the creation of comprehensive safety reports and submissions to regulatory authorities, which helps companies avoid penalties and maintain their reputation.

Pharmacovigilance and drug safety software is a vital tool that addresses manual data entry errors and manages the huge volume of safety data, among various other challenges. From clinical trials to post-marketing surveillance, this software is indispensable throughout the drug development lifecycle. Pharmacovigilance and drug safety software helps reduce adverse event processing time and improve patient safety through early signal detection. As regulations evolve and collaboration between European companies intensifies, the adoption of pharmacovigilance and drug safety software will become imperative for pharmaceutical companies and regulatory bodies. In 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) updated its guidelines on pharmacovigilance to adhere to international standards, highlighting the importance of robust pharmacovigilance and drug safety software. Also, in March 2024, The US Food and Drug Administration (FDA) provided guidance specifying the submission of investigational new drug (IND) safety reports for severe and suspected adverse events related to pharma drugs. These reports are submitted in electronic common technical document (eCTD) formats using PDF files. Further, the software ensures compliance with regulatory standards by facilitating the creation of comprehensive safety reports and submissions to regulatory authorities, which helps companies avoid penalties and maintain their reputation.