Automation & Agentic AI Platform
REGai is an Automation and Agentic AI platform built specifically for the Life Sciences industry. With over 8 years of experience, REGai has supported clients ranging from global Top 50 companies to small and mid-sized organizations, helping them adopt Automation, AI, or a combination of both based on their specific business needs and use cases.
REGai automation that can think, adapt, and act – grounded in your enterprise knowledge, governed by your rules, and ready to drive business goals at scale.
Automation
“Turn repeatable manual processes into automatic workflows”
For organizations seeking clear Traceable and Deterministic results WITHOUT any AI, REGai offers a robust “Zero AI” rule-based solution. Deploy smart automation to reduce cycle latencies, improve consistency, and minimize structural operational risk. For over several years, large rule libraries being developed in REGai daily that cover different business/functional areas covering data and documents focused to 100% traceability and compliance-ready outputs/decisions.
Agentic AI
“Add intelligence to your processes that require understanding, reasoning, or generation”
For teams ready to amplify their capabilities with cognitive processing, REGai provides Agentic AI options as separate solutions. Utilizing our secure & governed, local models, our AI agents augment human intelligence. It expertly handles contextual reasoning, dynamic data analysis, and content generation / checking, empowering your teams to focus on strategic decision-making while AI handles cognitive tasks.
REGai Solutions & Capabilities
Document Formatting Automation
REGai Document Formatting Automation uses AI to automate template styling, layout, and formatting for clinical, CMC, and regulatory documents. It ensures compliance with FDA/EMA standards, eliminating manual errors and accelerating submissions.
Document QC Automation
REGai Document QC Automation automates compliance verification, agency rules, consistency checks, with huge 600+ document check library for BioPharma (Clinical, CMC, Labeling, Regulatory, Submission documents) and Medical Device (Technical Files, IFU, Clinical) cutting manual effort by over 80% and speeding up review cycles.
Label Compliance & QC Automation
REGai Label Compliance & QC Automation checks (and fixes) global regulatory alignment, cross-examining product labels (CCDS to SPC or USPI), UDI structures, and artwork graphics to prevent content drift and ensure compliance across label changes/updates.
Publishing Automation
REGai Regulatory Publishing Automation turns Word and PDF files into submission-ready dossiers in minutes. Using 400+ automated rules (aligned with all major health agency requirements), it updates table issues, header/footer/TOC, bookmarks/hyperlinks, standardizes file names, and validates content, cutting publishing time and costs by 80%+. Guaranteed
Strategy, Intel & Impact AI Agents
REGai Strategy, Intel & Impact AI Agents continuously scan global regulatory changes, evaluate product impacts, and generate strategic pathways and action plans for Life Sciences teams, delivering 4x faster response times.
Project Management AI Agents
REGai Project Management AI Agents automate task creation, prioritization, risk mitigation, and status reporting for life science teams. They streamline complex workflows to reduce operational risks and ensure on-time project delivery.
Authoring AI Agents
REGai Document Authoring Agents automate drafting, formatting, and QC for several business/functional documents. They reduce operational costs by 40% and error rates to under 5% for several regulatory and functional documents.
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