- ArisGlobal introduces the new LifeSphere Regulatory platform for comprehensive management of regulatory affairs in life sciences.
- The platform integrates Regulatory Information Management (RIM) to enhance data quality and global oversight.
- Includes Products Compliance for managing medicinal product submissions according to IDMP requirements.
- Features a centralized Documents system for seamless document and content management.
- Offers Submission Management & Publishing for simplified submission creation and publishing workflows.
- Streamlines Labeling processes to ensure efficiency and compliance tracking.
- Utilizes Regulatory Analytics with preconfigured dashboards for reporting and analytical needs.
- Enhanced with LifeSphere NavaX for leveraging advanced cognitive computing capabilities.
Main AI News:
ArisGlobal, a leading innovator in life sciences technology and the creator of LifeSphere, has announced the launch of its new LifeSphere Regulatory platform. This platform represents a unified solution for end-to-end management of regulatory affairs, aimed at simplifying and optimizing regulatory workflows to enhance visibility and data integrity across organizations.
The comprehensive LifeSphere Regulatory Platform ecosystem includes several key products:
- Regulatory Information Management (RIM): Enhances data quality and global oversight with robust capabilities for managing product information, regulatory planning, tracking, and data management.
- Products Compliance: Facilitates management of medicinal product data submissions throughout submission, post-submission, and post-approval phases in accordance with IDMP requirements and operating models.
- Documents: Establishes a centralized content repository for seamless document and content management, featuring capabilities such as template management, workflows, advanced rendering, and permissions.
- Submission Management & Publishing: Streamlines submission and publishing workflows into a single solution, simplifying the creation, compilation, and publishing of submissions in various formats.
- Labeling: Ensures greater efficiency and consistency through streamlined end-to-end labeling change management and compliance tracking workflows.
- Regulatory Analytics: Utilizes preconfigured dashboards and reports to address common regulatory tracking, reporting, and analytical needs.
Industry leaders leveraging LifeSphere Regulatory can harness the platform’s capabilities further with LifeSphere NavaX, ArisGlobal’s advanced cognitive computing engine. This integration supports the latest advancements in artificial intelligence and machine learning, enhancing operational efficiency by up to 50%.
Early adopters of LifeSphere Regulatory with GenAI and LLM enhancements are benefiting from accelerated Health Authority interactions and improved regulatory intelligence capabilities. These enhancements enable proactive monitoring of regulatory updates and facilitate compliance amidst evolving regulations.
Ann-Marie Orange, CIO & Global Head of R&D at ArisGlobal, commented on the launch, highlighting ArisGlobal’s three decades of expertise in life sciences technology. She emphasized the company’s commitment to innovation through strategic acquisitions and technology R&D, positioning LifeSphere Regulatory as a pivotal advancement in regulatory affairs technology.
“For current LifeSphere Regulatory customers, the new platform offers enhanced capabilities and seamless migration to the latest technologies. It represents a significant leap forward in regulatory affairs technology, preparing organizations for future GenAI and LLM use cases,” said Orange. “We are excited to introduce LifeSphere Regulatory as a gamechanger in the industry, revolutionizing critical regulatory processes and delivering superior outcomes for life sciences organizations.“
Conclusion:
ArisGlobal’s launch of the LifeSphere Regulatory platform represents a significant advancement in the life sciences regulatory landscape. By integrating cutting-edge technologies like AI through LifeSphere NavaX, ArisGlobal not only enhances operational efficiency but also sets a new standard for regulatory affairs management. This move underscores their commitment to innovation and positions them as a leader in facilitating regulatory compliance and data integrity across the industry.
