Environmental, Health, and Safety, and Quality (EHSQ) compliance is no longer just a legal requirement, it’s a strategic imperative. EHSQ encompasses the policies and practices that keep workplaces safe, protect the environment, ensure product and process quality, and manage operational risk. Businesses are increasingly expected to demonstrate corporate responsibility, from addressing climate change and ESH […]

Pharmaceutical companies are facing mounting pressure to streamline their global labeling operations, which can be a risky and costly full-scale transformation. A targeted pilot provides a strategic, low-risk way to uncover current state gaps. Most importantly, it validates how emerging technologies like component-based authoring and generative AI can close those gaps. By offering stakeholders clear […]

The pace of regulatory change in life sciences is accelerating, and few areas reflect that more clearly than oncology. Project Orbis, an initiative led by the FDA’s Oncology Center of Excellence, offers a real-time case study in how regulatory content submission and generation are evolving. For this discussion, we spoke with a seasoned global labeling […]