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Regulatory Affairs Software

Experience a solution to your regulatory affairs software needs delivered in a simple, unified platform. Regulatory teams touch every aspect of development and need advanced tools to keep up with the latest regulatory bodies and standards.

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What is Regulatory Affairs Software?

In pharmacovigilance, Regulatory Affairs Software is a system that helps standardize as well as streamline all essential functions of a regulatory affairs team, including coordinating and managing regulatory submissions with the R&D, quality, manufacturing, clinical research, and other teams.

Why Choose LifeSphere Regulatory Affairs Software?

Accelerate Accurately

Enable faster time to market without sacrificing quality through a unified platform that tracks all regulatory team needs.

Advanced Compliance

Regulatory teams have to be on the forefront of new standards, LifeSphere Regulatory offers best-in-class support and full compliance with all major regulatory bodies.

Streamline Collaboration

Access your data and collect from a connected cloud-enabled solutions providing the most accurate information and a central repository for all teams.

Our LifeSphere Regulatory Affairs Software Suite

LifeSphere Regulatory RIMS

A true end-to-end regulatory information management solution that accelerates speed to market, reduces risk, and ensures team collaboration via cloud-enabled software

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LifeSphere Publishing

Manage submissions proactively with a powerful solution that allows teams to easily compile, publish, and validate regulatory submissions

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LifeSphere IDMP

Easily achieve compliance with new IDMP guidelines with the most up-to-date compliance will all future IDMP regulations, ensuring you’re prepared for today and tomorrow

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LifeSphere EasyDocs

Full-service document management that integrates where you need it throughout the drug development process and easily source every document needed for compliance

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What Are Some Common Features of LifeSphere Regulatory Affairs Software?

LifeSphere is trusted by hundreds of global pharmaceutical and biotech companies, health authorities, and CROs. Why is that? Because LifeSphere accelerates product development, maintains compliance, and streamlines collaboration–enabling you to impact global health.

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Related Products
LifeSphere RIMS empowers your team to do more across the Regulatory lifecycle. It’s not just another technology, it’s a holistic solution for all of your Regulatory needs in Pharma, Device, and combination organizations.
Regulatory Product Suite With LifeSphere® Publishing, you can compile, publish, and validate regulatory submissions with support for all major global eCTD requirements. Designed to ensure your organization’s compliance, LifeSphere IDMP is built to be interoperable and work with any RIMS or third-party software, making it the ideal solution to meet IDMP compliance. In the development lifecycle, documentation seems endless. Bring your data and documentation together in an easy-to-use, cloud based solution designed specifically for life sciences organizations. Your team needs support beyond just another digital file system, and LifeSphere EasyDocs can help you to:

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Trusted by Leaders Across the Platform

LifeSphere Regulatory Resources

Speed. Quality. Collaboration. Delivered in One Simple Unified Platform

LifeSphere Regulatory Affairs software 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.

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ArisGlobal’s LifeSphere IDMP Requirements, Readiness and Capabilities Acknowledged in Gens & Associates Reports

ArisGlobal currently has 19 of the 22 requirements available in their IDMP solution that were reviewed in the report, leading the other vendors evaluated. Gens’ industry report is a benchmark for IDMP vendors as they determine their cross-functional approach, improve automation as a core organizational goal and achieve IDMP/SPOR compliance.

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Webinar

Regulatory Affairs Transformation Drivers for Small and Medium Life Sciences Companies

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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

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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.

Learn more
White Paper: The Evolution of Signal Detection and Management   View More