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.
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.
Precision automation ensures you’ll never miss a deadline. Pre-validation prior to submissions certifies complete and accurate submissions every time.
Seamless transitions between Regulatory Affairs and operations in a single platform with 360° visibility into progress via interactive dashboards.
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.
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.
Partnering With the Industry’s Best
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
Of Top 50 Biopharmas
80% of the top 50 biopharma companies are our clients
80% potential efficiency gains driven by our Nava cognitive computing engine
30% immediate cost savings potential via our advanced automation capabilities
100% compliance with all present and upcoming regulatory standards