Watch Now: Regulatory Information Management Innovations in 2024
Transform regulatory performance with innovative, purpose-built technology
with One Regulatory Solution
Truly transformative regulatory technology empowers life sciences organizations to evolve by embracing new processes and continuing to pursue strategic objectives that were once out of reach. LifeSphere Regulatory is a purpose-built, end-to-end platform that helps Regulatory stakeholders worldwide work more effectively by seamlessly connecting teams, data, and processes.
Efficient management of global projects
Intelligent automation and centralized affiliate management to save considerable time and effort managing a global product portfolio.
Purpose-built to reduce complexity
Regulatory solutions to meet various market needs (biopharmaceuticals, medical devices and combination products) at any stage of development (investigational stage and marketed products).
Greater trust in authoritative data sources
Connected data and content shared between cross-functional teams and with third-party partners strengthens confidence in authoritative data sources.
360° visibility for informed decision making
Dashboards and analytics to break down barriers between Regulatory Affairs and Operations and embed strategic goals into operational execution for more informed management from strategy through approval.
LifeSphere Regulatory Platform Ecosystem
A transformative, end-to-end regulatory information management solution that creates efficiencies through intelligent automation, accelerates speed to market, reduces risk, and enables cross-functional and third-party collaboration via cloud-enabled software. LifeSphere RIMS is IDMP compliant, and purpose-built to meet the unique needs of the life sciences industry.
LifeSphere Investigational Product RIMS
A purpose-built regulatory solution for investigational-stage companies that reduces organizational complexity and upfront costs by focusing on high-priority capabilities like investigational submission and dossier planning, clinical trial authorization tracking, and health authority commitment management.
Collect, maintain, and enrich data compliant with IDMP and xEVMPD regulations while taking advantage of the agreed upon global standards that make it possible to standardize the electronic exchange of medicinal product information.
Manage submissions proactively with a powerful solution that supports all major global health authorities. LifeSphere Publishing allows teams to easily compile, publish, and validate regulatory submissions
LifeSphere Intelligent Content Management
Easily create, control, and manage 21 CFR Part 11 compliant documents shared with team members and third-party authors. Underpinned by shared architecture, LifeSphere Intelligent Content Management is a unified platform to manage documents and data across the entire LifeSphere portfolio.
LifeSphere Regulatory Advantages
To increase efficiency and stay ahead of regulatory submission deadlines, intelligent automation eliminates manual effort in creating dossiers, building workflows, setting task deadline triggers, and more.
By embracing interoperability and open architecture, LifeSphere Regulatory enables cross-functional and third-party collaboration, which eliminates the need to share data and documents outside of a validated, compliant system.
Rally around a single source of truth by connecting regulatory, clinical, and safety data points through a Central Company Product Dictionary (CCPD).
Improve patient safety and proactively respond to disruptions like drug supply chain issues by utilizing a solution that’s compliant with current and future global product data standards like IDMP and xEVMPD.
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Data Backed Benefits –
LifeSphere Regulatory by the Numbers
Efficiency gain by a Contract Research Organization (CRO) through integration of client systems and real-time visibility
Minutes of processing saved per document through seamless stakeholder transitions across the regulatory lifecycle and intelligent automation
Compliance with health authority requirements and global product data standards