Astra Zeneca aimed to ensure that it met regulatory and safety standards through scientific excellence and effective global processes.
The company wanted to streamline and standardize all patient safety and regulatory process workflows across its seven regional centers, and decided to partner with TCS to implement this industry first solution where safety and regulatory maintenance activities were integrated.
TCS manages routine regulatory maintenance and safety- for Astra Zeneca’s products.
TCS integrated processes in patient safety and regulatory services, and undertook end-to-end post-approval lifecycle maintenance and surveillance activities for 70+ established products and 100+ products in development in 130+ countries for Astra Zeneca. Our workflow solution ensured real time tracking across global delivery centers, employing 500+ experienced pharmacists and physicians, that formed the safety plus regulatory teams.
Our adverse event case processing operation was inspected by Food and Drug Administration (FDA, US), Medicines and Healthcare products Regulatory Agency (MHRA, UK), and Swedish health authorities with no critical or major findings.
streamline and standardize all patient safety and regulatory process workflows across its seven regional centers. It was an industry-first solution, where safety and regulatory maintenance activities were integrated.
