Our RIMS Software is the industry’s most innovative way to manage the entire regulatory lifecycle.
Built for today. Ready for tomorrow.
Speed. Compliance. Collaboration.
Delivered in one simple unified platform.
LifeSphere® RIMS software delivers end-to-end regulatory information management in an all-new, easy-to-use cloud application that accelerates speed to market, reduces risk and streamlines collaboration across teams.
Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements.
Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality.
Future-Proof Your Compliance
Reduce risk and stay compliant with the latest regulatory requirements thanks to scalable cloud architecture that provides continuous innovation via free and seamless upgrades.
LifeSphere RIMS software has been built from the ground up with a deep understanding of the regulatory lifecycle, offering a best-in-class standard configuration with full support for xEVMPD and IDMP data standards.
LifeSphere RIMS software seamlessly connects with LifeSphere® EasyDocs, a modern cloud content management platform, to provide a single source of truth for regulatory data and documents across R&D business processes, and LifeSphere® Publishing, a submissions management system with full support for all major global eCTD requirements. The result is real-time collaboration and visibility across all core regulatory processes.
Delivering Real Results to a Global Client Base
Of Top 50 Biopharmas
80% of the top 50 biopharma companies are our clients
Leader in Life Sciences
Building software to streamline life sciences innovation
100% compliance with all present and upcoming regulatory standards
Speed. Quality. Collaboration.
Delivered in one simple, unified platform.
LifeSphere RIMS is unified regulatory
application designed to streamline cross-functional collaboration across the entire organization.
Regulatory Affairs Transformation Drivers for Small and Medium Life Sciences Companies
Regulatory 2025: Developing an Effective 10-Year Strategy for Technology-Enabled Regulatory Transformation
To achieve an objective of regulatory 2025 and beyond, companies will need to harmonize processes and implement a central technology platform. They will need to establish a platform from which the rest of the organization can consolidate data and proactively measure metrics internally.
Not Your Average RIMS: Managing Increasing Complexity in Regulatory Affairs
Managing the submission of medicinal products, medical devices, and biologics to regulatory agencies is growing more complicated all the time. To streamline the processes that go into creating and tracking these submissions, life science organizations are increasingly relying on Regulatory Information Management Systems, or RIMS.
Partnering With the Industry’s Best
Simplify the Regulatory Lifecycle
Manage the entire regulatory lifecycle in a single platform. Streamline planning and tracking of interactions, commitments and obligations, as well as document and dossier management, publishing, reporting, and data standards compliance.
Superior Automation Capabilities
Automation-assisted workflows – including intelligent task assignment, submission planning, and performance tracking – and pre-configured templates help expedite regulatory submission and dossier planning.
Easy Access to Central Source of Documents and Data
Access up-to-date documents and data easily with seamless connectivity to LifeSphere® EasyDocs, and third-party document management systems.
Support for Medical Devices
Supports medical device registrations, submissions tracking, and compliance to FDAGUDID and EU EUDAMED UDI regulations.
Full xEVMPD Compliance and IDMP-Readiness
Full support for xEVMPD, with UDI and IDMP-readiness to ensure future compliance.
eCTD Submission Lifecycle Support
Manage the submission lifecycle, with full support for all major global eCTD requirements, including FDA applications and submissions.
Fast, knowledgeable teams adhere to industry best practices to get your teams up and running quickly.
No Extensive Training Needed
Designed to be easy and intuitive to use, with an interface designed for users of all skill levels.
Connects with existing systems via open architecture, leveraging API connectors, and web services.
Central Company Product Dictionary
Unified cross-functional collaboration across your safety, clinical and regulatory teams for substances, products, and authorizations allowing multiple systems to work together.