Regulatory Compliance Management Software

All life science organizations must comply with the state, federal, and international laws and regulations in which they operate. Regulatory compliance refers to the set of processes, procedures, and guidelines that govern how organizations comply with necessary regulations to protect sensitive information. Maintaining compliance as you scale can be challenging and open you up to potential legal ramifications.

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LifeSphere Regulatory Compliance Software

When it comes to compliance, it generally requires a significant investment as well as a change in business processes. Having demands placed on pharma companies to safeguard the supply chain from theft, aberration, and counterfeiting, we strongly believe that you should gain additional value and insights from your regulatory software compliance investment. LifeSphere Regulatory Compliance Software uses proprietary software that drives our customers’ organizations to new levels of supply chain productivity.

Features of LifeSphere Regulatory Compliance Management Software

With our regulatory compliance software, customers and consumers increase their demand for transparency that are driving exponential growth in both product control and regulatory data requests.

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.

What Are Some Common Features of LifeSphere Regulatory Compliance Software?

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.

Unified Documents and Data: Easily access up-to-date documents and data, as well as authoring and collaboration tools, with LifeSphere EasyDocs.

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.

Easy Integration: Connects with existing systems via open architecture, leveraging API connectors and web services.
Worry-Free Implementation: Fast, knowledgeable teams adhere to industry best practices to get your teams up and running quickly.

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Trusted by Leaders Across the Platform

LifeSphere Regulatory Resources

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.

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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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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

Watch webinar

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