End-to-end functionality helps cut skyrocketing costs of compliance and removes workflow inefficiencies

• The cloud-based platform demonstrates 50% + efficiency gains across Regulatory Operations by bringing together data, content, and processes in a single ecosystem.
• Platform is interoperable with LifeSphere Safety and Quality systems.
• Organizations have the option to embed LifeSphere NavaX, ArisGlobal’s next-gen cognitive computing engine, leveraging GenAI and LLMs to support content ingestion, generation, and enhanced insights. 

Boston, Massachusetts, USA – July 11, 2024 – ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today announced the launch of its new LifeSphere® Regulatory platform, a unified platform for end-to-end regulatory affairs management. The platform simplifies and reinvents the regulatory workflow processes, allowing organizations to improve visibility and data quality.

The new LifeSphere Regulatory Platform ecosystem of products includes:

• Regulatory Information Management (RIM) – Increases 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 – Establishes a single content repository for seamless document and content management, including template management, workflows, advanced rendering, and permissions.
• Submission Management & Publishing– Consolidates submissions and publishing workflows in a single solution that makes it simple to create, compile, and publish submissions in any format.
• Labeling – Drives greater efficiency and consistency by streamlining end-to-end labeling change management and compliance tracking workflows.
• Regulatory Analytics – Leverages preconfigured sets of standard dashboards and reports addressing common regulatory tracking, reporting, and analytical needs.

Industry leaders utilizing LifeSphere Regulatory can further power the platforms’ capabilities with LifeSphere NavaX, ArisGlobal’s next-generation cognitive computing engine, to leverage the latest GenAI and LLM features.

Today, early adopters can leverage GenAI and LLM enhancements that are driving upwards of 50% efficiency gains, including:

• Health Authority Interactions – Accelerate the intake of Health Authority (HA) communications and drive transparency and consistency in HA interactions.
• Regulatory Intelligence – Monitor for regulatory updates and build an intelligence knowledgebase to facilitate up-to-date compliance amid changing regulations.

In 2023, ArisGlobal launched LifeSphere NavaX, which is now able to power LifeSphere Regulatory for GenAI functionality today – and for future roadmap use cases.

Commenting on the launch, Ann-Marie Orange, CIO & Global Head of R&D shares, “With more than 35 years of experience in life sciences technology, ArisGlobal is the only technology company offering strong Safety, Regulatory, and Quality Management solutions powered with next-generation cognitive computing, delivering unmatched interoperability across the R&D IT ecosystem. Over the last 18 months, ArisGlobal has made significant investment in the strategic acquisitions of Amplexor Life Sciences and SPORIFY, along with technology R&D – and we’re not stopping.”

She continues, “For current LifeSphere Regulatory customers, the new platform will provide an enhanced experience and the ability to deploy the latest technologies, all with simple migration. For organizations looking to drive ROI with a new technology approach to Regulatory Affairs, LifeSphere Regulatory is the most advanced option and a real gamechanger for this industry. The enhanced platform truly revolutionizes critical Regulatory processes and drives better outcomes for life sciences organizations by readying organizations for GenAI and LLM use cases — we’re thrilled to relaunch LifeSphere Regulatory to the market.”

ArisGlobal, with a series of new product innovations, is the first life sciences R&D technology company to unveil targeted solutions that make impactful use of GenAI in the industry. The company continues to host the industry-leading GenAI Council, convening top pharmaceutical executives, academia, and AI thought leaders to further fuel adoption of next-generation technologies across life sciences.

To learn more about how LifeSphere Regulatory and NavaX can transform your organization’s Regulatory Affairs management, join us for an exclusive webinar on August 7, 2024.