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Revolutionizing Regulatory Information Management


With constantly changing regulations, global team alignment can be challenging for Regulatory teams.

LifeSphere Regulatory provides a comprehensive solution to everyday challenges with a holistic approach that goes beyond your average RIMS. We are revolutionizing Regulatory Information Management, and we invite you to join the revolution.

Introduction

More Than Your Average RIMS

Dossier planning and assembly, content, commitments, obligations, interactions, submissions, publishing, workflow automation, and interactive dashboards are just a few examples of our holistic approach to Regulatory. LifeSphere Regulatory reduces the risk of human error, strengthens team collaboration, and empowers teams to easily navigate compliance in a single solution.

Reduce Risk

Precision automation ensures you’ll never miss a deadline. Pre-validation prior to submissions certifies complete and accurate submissions every time.

Strengthen Collaboration

Seamless transitions between Regulatory Affairs and operations in a single platform with 360° visibility into progress via interactive dashboards.

Interoperability

Data requirements continue to increase for Regulatory Affairs. With LifeSphere Regulatory you can be assured that the data you need is connected and secure within LifeSphere RIMS.

Simplified Compliance

We are not only the market leader in IDMP readiness, we are prepared for all current and future standards. With LifeSphere Regulatory you can rest easy knowing you’ll always remain compliant.

Resources

Regulatory 2025

Developing an effective 1-year strategy for technology-enabled regulatory transformation.

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.

IDMP Readiness Checklist

A guide to preparing for the new ISO standard.

Connected Data, Interoperability Enable Greater Compliance and Beyond

Regulatory teams serve as the common thread of pharmaceutical research and development, connecting each domain on a drug’s journey to approval.

Delivering Real Real Results to a Global Client Base

80%

Of Top 50 Biopharmas

80% of the top 50 biopharma companies are our clients

80%

Efficiency Gains

80% potential efficiency gains driven by our Nava cognitive computing engine

30%

Cost Savings

30% immediate cost savings potential via our advanced automation capabilities

100%

Compliance

100% compliance with all present and upcoming regulatory standards

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