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
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.
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.
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.
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
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
Interactions
Intelligence
Learn More About
LifeSphere Regulatory
Data Backed Benefits –
LifeSphere Regulatory by the Numbers
Efficiency gain by a Contract Research Organization (CRO) through integration of client systems and real-time visibility
Minutes of processing saved per document through seamless stakeholder transitions across the regulatory lifecycle and intelligent automation
Compliance with health authority requirements and global product data standards