Regulatory & Safety Documentation - software & AI news

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

Showing 27 results
A surgical video camera in an operating room

Jun 17, 2026

Uncovr Secures $7M Seed Funding for AI Surgical Documentation Platform

Uncovr has successfully raised $7 million in seed funding to enhance its AI-driven surgical documentation platform, aimed at automating procedural coding and clinical documentation.Led by Index Ventures, this funding round also saw contributions from Seedcamp, Frst, No Labels Ventures, and several notable healthcare figures, including the founders of Digital Surgery and Color Health. Uncovr, founded in 2025 by Ines Iraki, Johann Diep, and Eric Vibert, M.D., Ph.D., leverages surgical video and in
A clipboard with safety reports in a clinical office setting.

Jun 13, 2026

UCB Transforms Safety Operations with Veeva Safety Suite in Collaboration with ELIQUENT Life Sciences, Pinnaxis, and Daelight Solutions

UCB has successfully implemented the Veeva Safety Suite, marking a significant advancement in its global safety operations through a collaboration with ELIQUENT Life Sciences, Pinnaxis, and Daelight Solutions.The Veeva Safety Suite, which includes tools like Veeva Safety, SafetyDocs, Safety Signal, and Safety Workbench, offers a comprehensive solution for pharmacovigilance. This transition to a unified, cloud-based platform enhances UCB's case processing, signal detection, and reporting capabili
A minimalist representation of a pill and a safety shield in a dark color scheme.

Jun 12, 2026

Veeva Highlights UCB Safety Suite Win And AI Platform Push For Upside

Veeva Systems has recently secured a significant deal with UCB to centralize its global pharmacovigilance operations using the Veeva Safety Suite, alongside launching its Falcon agentic labor platform aimed at automating life sciences workflows.This announcement highlights Veeva's strategic push into advanced AI capabilities with the introduction of Vault AI, which is designed to enhance efficiency in research and development as well as quality assurance processes. These developments come at a t
A clinical document on a desk in a medical office

Jun 11, 2026

How Automation and AI Transform Pharmacovigilance

The landscape of pharmacovigilance (PV) is undergoing a significant transformation due to the integration of automation and artificial intelligence (AI), driven by the increasing volume of adverse event (AE) reports and the need for efficient processing.The traditional manual approach to handling AEs is becoming unsustainable, as evidenced by the FDA's Adverse Event Reporting System (FAERS) recording over 2.1 million potential safety signals in 2023, a dramatic rise from 2011. This surge, couple
A pill bottle and tablets on a pharmacy shelf in dim light.

Jun 11, 2026

MHRA targets medicine safety with new AI sandbox

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is launching a new initiative aimed at enhancing medicine safety through artificial intelligence (AI). This regulatory 'sandbox' will serve as a controlled environment for pharmaceutical companies and researchers to test AI tools in collaboration with regulators.The initiative focuses on how AI can improve the assessment of medicine safety and efficacy, helping to predict risks and side effects more accurately. By establish
Flat silhouette of a stack of papers representing regulatory documentation burdens in healthcare.

Jun 5, 2026

Collate nears a $1 billion valuation and Harrison.ai grows

The rise of artificial intelligence in healthcare is exemplified by the recent funding success of Collate and the expansion of Harrison.ai, showcasing the transformative impact of technology in the sector.Collate, an AI startup specializing in life sciences documentation, has successfully raised $95 million, bringing its valuation close to $1 billion. Founded by Surbhi Sarna and Nate Smith, the company has developed tools that significantly reduce the burdens of regulatory and clinical trial pap
A minimalist illustration of a folder and document representing administrative tasks in life sciences.

Jun 5, 2026

Collate Raises $95M to Transform Life Sciences AI

Collate has successfully secured $95 million in a recent funding round, elevating its valuation to nearly $1 billion and highlighting the growing venture capital interest in AI applications within the life sciences sector.This funding, led by Redpoint Ventures alongside other notable investors such as First Round Capital and Conviction Partners, brings Collate's total capital raised to $125 million in less than 18 months. The startup aims to address the overwhelming administrative burdens faced
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