THE FUTURE OF REGULATORYINFORMATION MANAGEMENT

“RIM is being viewed as an Enterprise Asset and RIM systems must be able to exchange information with other critical enterprise capabilities (e.g., ERP) real time.”

“…As companies connect to other functional areas and apply artificial intelligence and predictive analytics methods, we should witness growing strategic value, operating efficiency and reduced compliance risk as a natural outcome.”

- GENS & Associates*

LifeSphere® Regulatory

Integrating Compliance with Regulatory Processes Over the Entire Product Lifecycle

Performance metrics, KPIs, reports and analyses for improved e�ciency

Streamlined publishing and content management

Global data standards compliance (xEVMPD, IDMP, UDI and beyond)

Intuitive, end-to-end handling of all regulatory a�airs processes by headquarters, regulatory operations, regional managers and local a�liates

LifeSphere RIMS

LifeSphere IDMP LifeSphere Publishing

LifeSphere Analytics

Increasing Compliance Audits

Planning &Tracking Ine�ciencies

Low A�liate RIM Adoption

Obsolete Software & Costly Upgrades

Complex Global Regulatory Requirements

Lack of Cross-Department Visibility

Low DataQuality Confidence

Limited, Real-Time Submissions Visibility

1

2 3

4Current Challenges

Based on 4 Key Tenets: Open Architecture –

Multi-Tenant Cloud – Cognitive Computing & Automation – Industry Standard Practices

Current Challenges

Delivering Powerful Benefits

Provides real-time visibility of regulatory activity

Strengthens data quality with reduced workload

Enhances demand forecasting, submission planning & performance tracking

Improves cross-department integration e�ciencies

Increases a�liates participation for global RIM rollouts

Lowers total cost of ownership & avoids upgrade headaches

Product & Clinical Trial Registrations

Submissions Planning & Tracking

Global Change Management

Health Authority interactions

Obligations & Commitments

Data Stanndards Compliance xEVMPD, IDMP, UDI

Document & Dossier Management

Publishing

Business Analytics

Regulatory Intelligence*

Label Management*

Cloud-Based SaaS

Learn how leading pharmaceutical, biotech, contract research organizations and health authorities are transforming Regulatory Affairs with LifeSphere Regulatory.

www.arisglobal.com/products/lifesphere-regulatory/

USED BY

Customer Successes

30+ Pharmas and CROs worldwide

10 of Top 50

5 of Top 20

4 of Top 1040%

25%

20%

*World Class Regulatory Information Management Whitepaper; Connections to Supply Release, Product Change and QMS - 2018 Fall Edition *Upcoming modules © 2019 ArisGlobal LLC. All rights reserved. All trademarks are the property of their respective owners and are acknowledged as such.