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’

Product Compliance

Streamline product lifecycle management and ensure data submission compliance.

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Product Compliance

Streamline product lifecycle management and ensure data submission compliance.

Book a Demo

ROI Calculator

LifeSphere® Technology is trusted by these industry leaders:

Product Compliance

Product Compliance enables efficient management and exchange of product data according to xEVMPD/IDMP requirements.

Standardized Processes

Standardize product data governance and lifecycle management.

Single Source of Truth

Enable increased consistency and quality of data via a controlled and centralized environment for medicinal product data facilitating reuse, impact assessment and data updates.

Enhanced Compliance

Ensure adherence to agency requirements and compliance with xEVMPD and IDMP requirements without the need for technical knowledge.

Process Automation

Automate the creation and update of medicinal products as part of the overall RIM lifecycle.

Features

Deliver real value with Products Compliance.

Product Data Management

Enhance product data standardization and lifecycle management.

xEVMPD Support

Embedded workflows for xEVMPD submission and data maintenance.

IDMP Compliance

Built-in IDMP support and validation according to the regional Implementation Guidelines.

Interoperability

Utilize direct gateway connectivity and SPOR integrations.

Data Enrichment

Automate data extraction and validation for enhanced data quality.

Interactive Dashboards

Gain actionable insights into managing product information.

Discover NavaX

the latest automation from LifeSphere

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Discover NavaX

the latest automation  from LifeSphere

Learn More

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Product Data ComplianceMladen Prenc2024-12-30T12:38:29+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.

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