Skip to content
Platform Regulatory

The most innovative, end-to-end Regulatory platform, powered with Gen AI

Reimagine the value Regulatory can provide.

Watch Now: Regulatory Information Management Innovations in 2024

OVERVIEW

See why it’s time to reimagine the value you can gain from Regulatory.

LifeSphere® Regulatory goes beyond legacy systems by seamlessly bringing together your data, content, processes and embedding the latest technologies across the end-to-end Regulatory lifecycle, including Gen AI and LLM features powered by LifeSphere NavaX™.

Benefits

LifeSphere Regulatory Advantages

Checkmark in circle icon

Cutting-Edge Automation

Drive to 80% efficiency gains and save employees hundreds of hours by implementing the most advanced intelligent automation, including Gen AI and LLMs.

Connecting nodes icon

End-to-End Regulatory

Seamlessly bring your Regulatory data, content, and processes together in a single, unified platform that provides access to end-to-end capabilities.

Globe icon

Consistent Global Compliance

Gain access to the most comprehensive and up-to-date out-of-the-box compliance, as well as real-time transparency into compliance status.

Bar Graph icon

Flexibility & Scalability

Tailor your Regulatory platform to fit your specific needs as they change and evolve over time via an interoperable and modular SaaS approach.

Products

LifeSphere Regulatory Platform Ecosystem

RIM

Increase data quality, global oversight, and control with robust capabilities for product information management, regulatory planning, tracking and data management.

Products Compliance

Manages medicinal product data submissions through submission, post-submission, and post-approval according to the IDMP requirements and operating model.

Documents

Establish a single content repository for seamless document and content management, including template management, workflows, advanced rendering, and permissions.

Submissions

Consolidate submissions and publishing workflows in a single solution that makes it simple to create, compile, and publish submissions in any format.

Labeling

Drive greater efficiency and consistency by streamlining end-to-end labeling change management and compliance tracking workflows.

Regulatory Analytics

Leverage a preconfigured set of standard dashboards and reports addressing common regulatory tracking, reporting and analytical needs.

Interactions

Powered by LifeSphere NavaX for Regulatory, accelerate the intake of Health Authority (HA) communications and build a knowledgebase driving transparency and consistency in HA interactions.

Intelligence

Powered by LifeSphere NavaX for Regulatory, monitor for regulatory updates and build an intelligence knowledgebase to facilitate always up-to-date compliance amid changing regulations.

Learn More About

LifeSphere Regulatory

Results

Data Backed Benefits –
LifeSphere Regulatory by the Numbers

Percentage Graph displaying 30%
25%

Efficiency gain by a Contract Research Organization (CRO) through integration of client systems and real-time visibility

Percentage Graph displaying 80%
15+

Minutes of processing saved per document through seamless stakeholder transitions across the regulatory lifecycle and intelligent automation

Percentage Graph displaying 100%
100%

Compliance with health authority requirements and global product data standards

Contact Us

Leverage the latest GenAI and LLM innovations powered by LifeSphere NavaX   Learn More

Join us at Breakthrough2024 to explore life sciences transformation through Intelligent Automation

Register Here