The pharmaceutical industry is significantly transforming, driven by escalating R&D costs, rising competition, and a rapidly evolving global regulatory landscape. In this dynamic environment, regulatory affairs have emerged from their traditional compliance-focused roles to become strategic business agility enablers. Enterprises are increasingly recognizing the potential of AI, generative AI, and agentic AI to reduce manual workloads, accelerate time-to-market, and improve the accuracy and consistency of regulatory submissions. This report provides comprehensive insights into AI adoption’s current state in regulatory affairs, highlighting key challenges, value drivers, and investment trends. It explores prioritized strategic and operational use cases across regulatory processes and outlines how enterprises can overcome adoption hurdles through robust governance frameworks. The report also examines specialized providers’ evolving role in this transformation. Through their domain expertise, technology capabilities, and scalable solutions, these providers help reduce risk, ensure compliance, and enable faster time-to-market. Industry Life Sciences BPS Geography Global Contents In this report, we examine: Regulatory affairs’ evolving role in life sciences Current and future AI investment trends across pharma enterprises Leading AI use cases in regulatory strategy and operations A governance framework to address AI adoption challenges The strategic role of regulatory affairs specialist providers in accelerating AI adoption Memberships Life Sciences Business Process Sourcing and Vendor Management

A series of device malfunctions, coupled with technological and scientific advances in the medical device industry, drove regulators to revamp the decades-old European medical device regulations (the Medical Device Directive or MDD and the In Vitro Diagnostic Directive or IVDD). The European Commission introduced the European Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR) on May 26, 2017, with the actual launch expected in May 2021 and May 2022 respectively. The primary goal was to strengthen the safety and effectiveness of medical devices commercialized in the European market. EU MDR was earlier set for launch in May 2020, however, a series of overwhelming events – primarily the global COVID-19 pandemic, along with the industry’s under-preparedness to comply – has forced EU regulators to consider a one-year implementation delay. The new regulations put stringent controls on device classification, clinical evaluation, and post-market surveillance and are expected to have unique implications for all stakeholders across the industry. To achieve EU MDR and IVDR compliance, we recommend medical device manufacturers to take an organization-wide approach with C-suite involvement and redefine their compliance strategies to remain relevant in the European market. Scope Industry: medical devices Geography: European Union Contents In this viewpoint, we discuss the following topics: An overview of EU MDR & IVDR and their objectives Challenges in implementing the new regulations The impact of EU MDR & IVDR on the medical device industry How are medical device manufacturers, CROs, and services providers likely to react to these new regulations? What are the steps being taken by players across the ecosystem (to ensure compliance with the new regulations? Membership(s) Life Sciences IT Services (ITS)