Regulatory & Safety Documentation - software & AI news

Daily news on software, AI, and companies shaping regulatory & safety documentation.

Showing 20 results
A regulatory document in a biotech lab

Jun 3, 2026

AI Has Arrived In Biotech CMC Amid Patchwork Governance

AI integration in biotech's regulatory affairs and CMC is advancing rapidly, but governance frameworks are struggling to keep pace.Artificial intelligence (AI) is increasingly being adopted in regulatory affairs and Chemistry, Manufacturing, and Controls (CMC) within biotech companies. Many organizations are utilizing AI for tasks such as drafting documents, summarizing data, and developing responses to health authorities. However, this adoption often occurs without fully established governance
A flat illustration of a syringe with a droplet, representing drug development.

May 26, 2026

Novo Nordisk Bets on AI to Cut Drug Launch Timelines by Two-Thirds, Bengaluru Hub Takes Lead Role

Novo Nordisk is leveraging artificial intelligence to significantly reduce drug launch timelines, aiming for a two-thirds reduction in the process, according to a company executive. This initiative is part of the company's strategy to enhance its position in the growing obesity drug market.John Dawber, managing director for global business services, indicated that traditional timelines for drug launches, which could take up to a year and a half from the last patient visit to the first regulatory
A minimalist illustration of a smartwatch and a speech bubble representing digital health and social media.

May 21, 2026

AI, Digital Health Expand Drug Safety Monitoring

AI and digital health technologies are poised to enhance drug safety monitoring by leveraging real-world data sources, including social media and wearable devices, to identify medication side effects more swiftly than traditional methods.Recent research highlights the potential of AI and digital tools to transform pharmacovigilance by analyzing vast datasets from social media platforms like Reddit and X. These platforms can reveal patient experiences that often go unreported in clinical trials,
Flat illustration of a regulatory document and database icon in a minimalist style.

May 17, 2026

Claude's Corner: Rhizome AI — The FDA Whisperer for Biotech

Rhizome AI is poised to revolutionize regulatory affairs in the biotech sector by providing rapid access to critical FDA insights, effectively reducing the time and risk associated with regulatory submissions.Regulatory affairs can be a daunting task in biotechnology, often requiring extensive navigation through complex FDA guidelines and historical precedents. Rhizome AI aims to alleviate this burden with a platform that delivers precise regulatory intelligence. Utilizing a robust system built
A minimalist illustration of a syringe and vial on a dark background.

May 12, 2026

Graph AI: A service firm turned AI-native solution for pharma and life sciences

Graph AI is transforming pharmacovigilance by developing an AI-native Patient Safety Operating System designed to streamline the regulatory reporting process for pharmaceutical, biotech, and life sciences companies.Pharmacovigilance, a critical aspect of drug safety monitoring, involves continuous reporting of adverse events and compliance with regulatory requirements. Traditionally, this process has been cumbersome, relying heavily on outdated software tools and manual data entry, resulting in
A pill bottle and syringe on a lab bench in a dimly lit clinical setting.

May 2, 2026

Parexel Acquires Vitrana to Expand AI-Enabled Pharmacovigilance Capabilities

Parexel has announced its acquisition of Vitrana, a move aimed at enhancing its pharmacovigilance capabilities through AI technology. This strategic integration is set to streamline patient safety operations within Parexel's clinical development framework.The acquisition will allow Parexel to incorporate Vitrana's versatile platform, which is compatible with various safety databases, into its existing systems. This integration is designed to facilitate comprehensive pharmacovigilance processes,
A minimalist illustration of a pill bottle and safety shield in dark colors.

Apr 30, 2026

Parexel acquires Vitrana to strengthen AI-driven patient safety capabilities

Parexel has expanded its capabilities in patient safety by acquiring Vitrana, a move that enhances their integrated pharmacovigilance (PV) solutions through advanced AI and automation technologies.This acquisition allows Parexel to offer a comprehensive PV solution that is adaptable to various safety databases, thereby improving accuracy and compliance in a complex regulatory environment. As a result, Parexel aims to streamline operations and respond to the industry's growing need for unified se
A clinical data report on a lab bench with a notebook in the background.

Apr 28, 2026

Prezent launches Prezent Vivo, an AI-powered communication partner set to transform the life sciences industry

Prezent AI has introduced Prezent Vivo, an innovative communication platform aimed at enhancing efficiency and precision in the life sciences sector.Prezent Vivo is designed to integrate specialized AI capabilities with human expertise, addressing the unique challenges of communication in life sciences. The platform is built for biopharma companies and their agency partners, focusing on the need for accuracy in clinical data and regulatory communications. Traditional AI tools often fall short in