Regulatory & Safety Documentation - software & AI news

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

Showing 33 results
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Oct 15, 2026

Welo Life Sciences Announces Glass PV for AI-Enabled Pharmacovigilance Case Translation

Platform combines document extraction, specialistlinguistic review, and automated layout reconstruction to simplify adverseevent case translation.NEW YORK,October 14, 2026 — Welo Life Sciences, a WeloGlobal brand, today announced Glass PV,an AI-enabled pharmacovigilance case translation platform. Glass PV turns scanned adverse event documents, includinghandwritten notes, mixed languages, and complex layouts, into translated PDFs intheir structure at scaleAccording to WelocalizeLife Sciences’ mea
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Oct 14, 2026

Improve Pharmacovigilance Quality with AI-Enabled Case Intake, Upcoming Webinar Featuring Deloitte Leaders, Hosted by Xtalks

Learn practical approaches to applying AI in pharmacovigilance, including quality controls, confidence indicators, auditability, and human oversight, through a live demonstration of AI-enabled case intake.TORONTO, Oct. 14, 2026 /PRNewswire/ -- Pharmacovigilance intake processes must keep pace with the growing volume and variety of incoming data. Potential adverse events and product quality complaints can arrive through a variety of sources, including emails, websites and portals, chatbots, call
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Oct 8, 2026

Thunk.AI Publishes Open Benchmark for AI Automation in Pharmacovigilance Case Intake, Demonstrates 99%+ AI Reliability

Benchmark of 75 adverse-event reports measures how accurately AI agents triage cases and identify expedited regulatory reports under a written SOPSEATTLE--(BUSINESS WIRE)--Thunk.AIhas published a new benchmark that measures how reliably AI agents carry outpharmacovigilance case intake: the first pass a drug company makes over everyadverse-event report it receives. The benchmark, the data, and the scoringmethod are publicly available. The benchmark is the third in Thunk.AI’s "HiFi" series, follow
A regulatory document and pen on a conference table

Sep 26, 2026

DNAnexus Showcases AI-Driven Regulatory Data Strategy at Pharma Summit

DNAnexus is set to spotlight its AI-driven regulatory data strategy at the upcoming Global Pharmaceutical Regulatory Affairs Summit in Brussels, as highlighted by a recent LinkedIn announcement from the company.Jimita Parekh, the VP of Regulatory Technology & Innovation at DNAnexus, will discuss critical elements such as semantic alignment and structured data exchange, which are essential for the effective implementation of AI in electronic regulatory submissions. This focus underscores the comp
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Sep 25, 2026

AI agents target drug safety, protein discovery and secure health data analysis

Recent advancements in AI technology are revolutionizing the pharmaceutical industry by introducing specialized agents that enhance compliance and data governance.Veeva Systems has unveiled the Veeva Falcon Router, a tailored AI solution aimed at streamlining the handling of safety reports, quality complaints, and medical inquiries. This new tool is designed to efficiently direct these reports to the appropriate teams, thereby minimizing the need for manual processes. The Falcon Router will init
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Sep 23, 2026

Annovis Announces Partnership with Weave Bio, AI Regulatory Platform, in Preparation of NDA for Buntanetap in Alzheimer’s Disease

MALVERN, Pa., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced a collaboration with Weave Bio, an AI platform for regulatory content and knowledge management, in support of the planned New Drug Application (NDA) for buntanetap. Under the
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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