The COVID-19COVID-19 pandemic has posed significant challenges to regulatory frameworks globally, with pharmaceutical and medical device regulationMedical Device Regulation being at the forefront of the crisis. This paper explores the role of digital transformationDigital transformation in strengthening the resilienceResilience of the pharmaceutical regulatorySystem system in SerbiaSerbia during the pandemic. By leveraging digital tools, the Serbian Medicines and Medical Devices Agency (ALIMS)Medicines and Medical Devices Agency (ALIMS) was able to streamline regulatory processes, ensuring faster approval and distribution of critical medicines and medical devices. The study examines the technological adaptations made by ALIMS, including the integration of eServices and automation in decision-making, and assesses their impact on operational efficiency and the timeliness of regulatory responses. The findings highlight the transformative potential of digital solutions in enhancing regulatory capacity during health crises and offer insights into future improvements for building resilience in critical infrastructure. This paper contributes to the understanding of digital transformationDigital transformation in the regulatory context and provides a case study of how SerbiaSerbia responded to the challenges of the pandemic.