July 1, 2026 | Tata Consultancy Services Japan Ltd. (Headquarters: Minato-ku, Tokyo; President: Satish Thiagarajan; hereinafter referred to as Japan TCS) announced today the launch of two AI solutions that leverage generative AI to support medical writing and literature screening operations. In recent years, the pharmaceutical industry has seen a significant increase in the workload of safety management operations due to the growing volume of literature and related data, as well as the increasing sophistication of regulatory requirements in various countries. This has led to a need to create high-quality documents within limited timeframes while ensuring expertise, accuracy, consistency, and traceability, thereby increasing operational complexity. Meanwhile, in the pharmacovigilance (PV) domain, similar to pharmaceutical development, there is a high dependence on specialized personnel, and the shortage of such talent is becoming severe. Traditional, person-dependent operational structures are unable to avoid variations in quality and uneven distribution of workload, facing structural challenges that cannot withstand business expansion or increased load. Particularly in the Japanese market, it is difficult to apply the same systems used overseas directly to Japanese services due to the need to comply with Japan's unique regulatory requirements and provide Japanese language support. This poses a challenge to the advancement of automation and efficiency in the domestic PV domain. In response to these challenges, Japan TCS has combined its specialized knowledge accumulated over many years in medical writing, ICSR operations, and literature screening with the latest AI technology to develop and launch practical solutions that are GxP (Good x Practice) compliant. These solutions enable AI-based support for 1. primary draft creation in medical writing operations and 2. literature screening, supporting both Japanese and English languages. 1. AI Tool for Supporting Draft Cre