Integrate compliance with business process over the entire product management lifecycle
- Improves efficiency and productivity via automation, actionable analytics and intuitive user experience
- Reduces TCO and offers insulation to changing regulations with multi-tenant cloud-based solution
- Improves overall organizational compliance with regulatory information sharing via standard integrations and open architecture
Leading the Way in Regulatory Affairs and Regulatory Compliance Software
LifeSphere Regulatory is a powerful regulatory affairs and regulatory compliance software solution that offers an innovative, end-to-end approach for pharmaceutical regulatory affairs and integrates compliance with business processes over the product management lifecycle. Capabilities span core regulatory tracking and submission management capabilities, as well as integrations with document and dossier preparation, management and publishing.
A multi-tenant cloud-based regulatory solution, LifeSphere Regulatory enables quick deployment, lower total cost of ownership (TCO), easy upgrades and inexpensive fine-tuning to facilitate quick reactions to changing regulations. Powerful market-proven solutions that are built on industry best practices and compliant with regulations from the FDA and European Medicines Agency (EMA) help to bridge the information management gaps between regulatory affairs and other parts of the company.
Cloud-based regulatory information management system (RIMS) enables regulatory affairs to maintain a validated source of truth about all products globally in a central standards compliant data hub.
The LifeSphere Regulatory platform consists of the following modules:
Regulatory Information Management – LifeSphere® RIMS is a SaaS-based RIMS solution that leverages a process-based approach for tracking and managing all regulatory affairs submissions in a single solution
Regulatory Submissions Management System – As a Unified Solution, LifeSphere Publishing is part of ArisGlobal’s LifeSphere® Regulatory end-to-end cloud platform, providing a single source of truth across the entire regulatory organization and full compliance with regulatory standards
IDMP/Compliance Management – LifeSphere® IDMP is a complete solution to handle the technical, business and compliance challenges companies face with IDMP as well as XEVMPD and to support internal compliance