Regulatory & Safety Documentation - software & AI news

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

Showing 27 results
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Sep 21, 2026

Veeva Introduces Falcon Router for Agentic Triage of All Reporting Channels

PLEASANTON, Calif., Sept. 21, 2026 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced Veeva Falcon Router, an industry-specific agent to identify and route potential safety adverse event reports, product quality complaints, and medical inquiries to the correct teams with speed and consistency.Falcon Router will orchestrate triage and routing actions for biopharmas of all sizes, without the need for manual reconciliation. The initial focus will be on email and web intake, including Veeva
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Sep 3, 2026

Authenticx Expands Pharmacovigilance AI to Automate Downstream Safety Workflows With Accuracy

New capabilities build on Authenticx's established adverse event detection technology, connecting patient conversations with pharmaceutical manufacturers' existing safety workflowsINDIANAPOLIS, Sept. 3, 2026 /PRNewswire/ -- Authenticx, whose AI turns millions of healthcare conversations into system-critical intelligence for pharmaceutical, payer and provider organizations, announced expanded capabilities for its Pharmacovigilance (PV) AI Solution. Building on its 2024 safety-event detection, the
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Sep 3, 2026

Accelerate Regulatory Writing with Gen-AI Without Prompt Engineering, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn how generative AI can support regulatory writing without requiring complex prompt engineering. The featured speaker will discuss content-based mapping, document reuse and working directly within Microsoft Word to streamline regulatory document development. Attendees will also explore how this approach can improve consistency and efficiency while keeping medical writers in control of scientific judgment and content review.TORONTO, Sept. 3, 2026 /PRNewswire/ -- Generati
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Sep 2, 2026

Weave Bio Announces Collaboration with Takeda to Deploy AI-Native Regulatory Automation Across Key Drug Development Activities

Co-authored IND submission preparation study results demonstrate ~97% reduction in time to first draft and 60% overall timeline compressionSAN FRANCISCO--(BUSINESS WIRE)--#AI--Weave Bio, the leader in AI-native regulatory automation for drug development, today announced a collaboration with Takeda to deploy the Weave platform across 14 active programs in multiple global markets. The collaboration brings together Weave's AI capabilities and Takeda's regulatory expertise to support innovation in r
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Sep 1, 2026

Veeva Falcon Safety to Work with All E2B-Compliant Safety Systems Across Any Intake Channels

PLEASANTON, Calif., Sept. 1, 2026 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced Veeva Falcon Safety, an agentic safety operations product to streamline adverse event intake, case processing, and follow-up to reduce costs, increase speed, and maintain compliance for biopharma companies of all sizes.In addition to working seamlessly with Veeva Safety, Falcon Safety will provide intake and follow-up management for any E2B-compliant safety system, including Oracle Argus and ArisGlobal L
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Aug 14, 2026

Gulfstream Intelligence Launches Connected Regulatory Intelligence and Execution Platform for Pharmaceutical and Biotech Teams

Built by regulatory professionals with more than 25 years of industry experience, Gulfstream Intelligence connects regulatory intelligence, global labeling, gap assessment, health authority preparation, submission planning and regulatory document analysis in one platform.WELLINGTON, Fla., August 13, 2026 — GulfstreamIntelligence today announced the launch of its regulatory intelligence andexecution platform built specifically for pharmaceutical, biotechnology andlife science organizations.Develo
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Aug 13, 2026

Maguar Capital takes majority stake in pharma software specialist Schlafender Hase

Maguar Capital has announced its acquisition of a majority stake in Schlafender Hase, a software provider specializing in content verification for the pharmaceutical and medical technology industries.This strategic move by Maguar Capital, a German investment firm focusing on small to mid-sized B2B software companies, aims to enhance Schlafender Hase's capabilities in a market increasingly driven by stringent regulatory requirements. Founded in 2001, Schlafender Hase offers deterministic software
A minimalist illustration of a cloud with circuit patterns, representing cloud-native technology in life sciences.

Jul 23, 2026

Nordic Capital announces agreement to sell ArisGlobal to Dassault Systèmes, following its transformation into a scaled and AI-enabled life sciences platform

Nordic Capital has announced a definitive agreement to sell ArisGlobal to Dassault Systèmes, marking a significant milestone in the evolution of ArisGlobal as a leading software provider in the life sciences sector. This transaction represents Nordic Capital's full exit from its investment, following a successful partnership that transformed ArisGlobal into a robust, cloud-native platform enhanced by AI capabilities.Founded in 1989, ArisGlobal has developed its flagship LifeSphere® platform, whi
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Jul 16, 2026

One Click, Countless Hours: How AI Is Revolutionizing Safety Monitoring in Medtech

Artificial intelligence is transforming safety monitoring in the medical technology sector, significantly enhancing efficiency and data integration.The integration of AI into safety monitoring processes is reshaping how medical device companies manage post-market surveillance. Traditionally, safety teams faced a labor-intensive task of sifting through disparate data sources—complaint records, adverse event reports, and regulatory databases—all of which operated in silos. This fragmented approach
A vial of medication on a lab bench in a clinical setting.

Jul 7, 2026

MethodHub Software partners with Datafoundry to boost AI pharmacovigilance

MethodHub Software has entered a partnership with Datafoundry to enhance its AI-driven Pharmacovigilance (PV) solutions for the pharmaceutical and biotech sectors. This collaboration, announced on July 6, 2026, aims to provide comprehensive, technology-based solutions that meet the increasing demands of regulatory compliance and the complexities of global clinical data.The partnership will leverage MethodHub's expertise in PV operations and regulatory adherence, alongside Datafoundry's advanced
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Jul 7, 2026

MethodHub Software Shares Up 5% on Strategic AI Partnership with Datafoundry

MethodHub Software Limited has announced a strategic partnership with Datafoundry, aiming to enhance AI-driven pharmacovigilance and pharma-tech solutions for the life sciences sector. This alliance is expected to bolster MethodHub’s presence in the rapidly evolving healthcare technology market.The collaboration has already positively impacted MethodHub's stock, which saw an increase of nearly 5% following the announcement. MethodHub, with a market cap of approximately Rs. 164.50 crore, has been
A pill bottle and tablets on a pharmacy shelf

Jul 6, 2026

Methodhub Software Partners Datafoundry for AI-Driven Pharma Solutions

Methodhub Software Ltd. has partnered with Datafoundry to enhance pharmacovigilance through AI-driven solutions, aiming to streamline processes for over 40 global clients in the life sciences sector.The collaboration will leverage Datafoundry’s AI/ML capabilities to transform traditional pharmacovigilance operations, moving from manual to automated systems. This shift is expected to improve efficiency in case intake, signal detection, and literature monitoring, which are critical for pharmaceuti