Felix Arellano
Global Head of Drug Safety – Roche

‘From Planning to Launch: How to Implement a New Safety Database and Maximize ROI’

Hans van Leeuwen
Global Head of Regulatory Operations – Astellas

‘Achieving Interoperable Safety and Regulatory Platforms’

Julie Thomas
Vice President, Global Medical Safety Operations – Johnson & Johnson

‘LifeSphere NavaX: Driving Greater Value with GenAI’

Regulatory Planning, Tracking and Registration Management

Seamlessly coordinate regulatory information management throughout the product lifecycle.

Book a Demo

ROI Calculator

Regulatory Planning, Tracking and Registration Management

Seamlessly coordinate regulatory information management throughout the product lifecycle.

Book a Demo

ROI Calculator

LifeSphere® Technology is trusted by these industry leaders:

Regulatory Information Management (RIM)

RIM reduces data entry needs, improves data quality, and increases global oversight and control via robust capabilities to manage regulatory planning, tracking, and registration management.

Standardized Processes

Save time and effort by ensuring more streamlined and consistent end-to-end workflows for regulatory planning and tracking across all markets.

Enhanced Collaboration

Make it simple for your teams to work together with various stakeholders on global and national levels.

Single Source of Truth

Eliminate siloes and harmonize your operations by establishing a single area for worldwide registration activities and records.

Product Specifics

Ensure compliance with support for investigational and marketed drug/medicinal products, as well as active substances, devices, site registrations and more.

Features

Deliver real value with LifeSphere RIM.

Regulatory Planning & Tracking

Built-in support for planning your submissions, as well as tracking registrations, correspondence, commitments, and other key information.

Connectivity and Automation

Seamlessly work with your documents, submissions, interactions, labeling, product data and regulatory intelligence.

Global Coverage

Centralize global submission planning and tracking.

Localized Support

Support specific regional requirements and regulatory knowledge.

IDMP Compliance

Support for the IDMP target operating model.

Interactive Dashboards

Gain actionable insights into regulatory activities and registrations.

Discover NavaX

the latest automation from LifeSphere

Learn More

Discover NavaX

the latest automation  from LifeSphere

Learn More

Resources

Learn more about our collaborative partnership with customers.

"*" indicates required fields

Get started!

First Name*

Last Name*

Email*

Job Title*

Company Name*

HQ Country*

Area of Interest*

Purchase Timeframe*

Comments

This field is for validation purposes and should be left unchanged.

Regulatory Planning, Tracking and Registration ManagementMladen Prenc2024-12-30T12:37:43+00:00

ArisGlobal is a pivotal partner in the life sciences industry, specializing in solutions that drive drug development, safety monitoring, and regulatory compliance. We collaborate with more than 500 global life sciences companies, CROs, and government health authorities, including leading biopharmaceutical firms and regulatory bodies such as FDA, Health Canada, and NMPA.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China.

Quick Links

Follow Us