LIFESPHERE®
Regulatory Software
Speed. Quality. Collaboration.
Delivered in one simple, unified platform.
JUMP TO
Reimagined from the ground up, LifeSphere Regulatory delivers end-to-end regulatory information management in a unified cloud platform that accelerates approvals, reduces risk and streamlines collaboration across teams.
Accelerate approvals.
Save time and effort by managing the end-to-end regulatory process in a single cloud platform with unified data and documents. Native automation streamlines tasks and lets your team focus on what matters most.
Reduce risk.
Scalable cloud architecture delivers continuous innovation and stays up to date with the latest regulatory compliance standards, future-proofing your regulatory environment and reducing risk.
Streamline collaboration.
Unified with drug development applications to streamline cross-functional collaboration and provide a single source of truth across the entire organization.
OVERVIEW
LifeSphere® Regulatory
Regulatory information management, publishing and document management. Delivered in one simple, unified platform.
LIFESPHERE®
RIMS
LIFESPHERE®
Publishing
LIFESPHERE®
EasyDocs
LIFESPHERE®
IDMP
LIFESPHERE®
RIMS
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.
Learn More
LIFESPHERE®
Publishing
A powerful submissions management application that enables life sciences organizations to easily compile, publish, and validate regulatory submissions with full support for all major global eCTD requirements.
Learn More
LIFESPHERE®
EasyDocs
An all-new cloud platform that gives R&D teams one central location for managing documents and data, delivering efficiency, compliance, and enhanced collaboration across drug development workflows.
Learn More
LIFESPHERE®
IDMP
Enabling life sciences companies with existing RIM solutions to achieve compliance with xEVMPD, IDMP, UDI, SPL, and other standards, and collect data in an ISO IDMP-compliant fashion.
Key Products
BENEFITS
Speed. Quality. Collaboration.
The All-New LifeSphere Regulatory platform.
Move fast without sacrificing data quality.
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 Regulatory 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 standards.
Streamline collaboration between teams.
LifeSphere Regulatory is a fully unified regulatory platform designed to streamline collaboration across the entire organization, including headquarters and affiliates, and clinical, safety and quality teams.
Leveraging the cloud document management capabilities of LifeSphere® EasyDocs, LifeSphere Regulatory delivers a single source of truth for regulatory data and documents across R&D business processes. The result is real-time collaboration and visibility across the regulatory lifecycle.
Regulatory Webinars
Astellas’s Regulatory Collaboration Beyond Compliance
FACT SHEET
Speed. Quality. Collaboration.
Delivered in one simple unified platform
LifeSphere Regulatory delivers end-to-end regulatory information management in an all-new, fully unified cloud platform that accelerates speed to market, enhances data quality and streamlines collaboration across teams.
PRESS RELEASE
ArisGlobal’s LifeSphere IDMP Requirements, Readiness and Capabilities Acknowledged in Gens & Associates Reports
WEBINAR
Regulatory Affairs Transformation Drivers for Small and Medium Life Sciences Companies
BLOG
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.
FEATURES
End-to-End Coverage
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.
Full xEVMPD and IDMP-Readiness
Full support for xEVMPD, with UDI and IDMP-readiness to ensure compliance.
Worry-Free Implementation
Fast, knowledgeable teams adhere to industry best practices to get your teams up and running quickly.
Unified Documents and Data
Easily access up-to-date documents and data, as well as authoring and collaboration tools, with LifeSphere EasyDocs.
eCTD Submission Lifecycle Support
Manage the submission lifecycle, with full support for all major global eCTD requirements, including FDA applications and submissions.
Support for Medical Devices
Supports medical device registrations, submissions tracking, and compliance to FDA GUDID and EU EUDAMED UDI regulations.
Superior Automation Capabilities
Automation-assisted workflows – including intelligent task assignment, submission planning and performance tracking – and preconfigured templates help expedite regulatory submission and dossier planning.
No Extensive Training Needed
Designed to be easy and intuitive to use, with an interface designed for users of all skill levels.
Easy Integration
Connects with existing systems via open architecture, leveraging API connectors and web services.
PARTNERS
Partnering With the Industry’s Best
