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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


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™.


LifeSphere Regulatory Advantages

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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.

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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.

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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.

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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.


LifeSphere Regulatory Platform Ecosystem


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.


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


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


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.


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.


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


Data Backed Benefits –
LifeSphere Regulatory by the Numbers

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

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

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Compliance with health authority requirements and global product data standards

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

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