Orion Regulatory Affairs Lifecycle Management (ReALM®)
Overview
What is Orion Regulatory Affairs Lifecycle Management (ReALM®)?
Orion Innovation is a digital transformation and product development services firm. Headquartered in Edison, NJ, with a global team of over 6000 associates, with engineers in 13 major delivery centers spread across the Americas, Europe, and APAC. Operating for over…
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- Tech Details
What is Orion Regulatory Affairs Lifecycle Management (ReALM®)?
Orion Innovation is a digital transformation and product development services firm. Headquartered in Edison, NJ, with a global team of over 6000 associates, with engineers in 13 major delivery centers spread across the Americas, Europe, and APAC. Operating for over 25 years, Orion boasts transformative business solutions rooted in digital strategy, experience design, and engineering, to empower clients to operate with agility at scale.
Orion has been serving the pharma and life sciences industry with business solutions for over a decade, and provides software solutions and services in areas that, they state, have traditionally been slow to exploit the power of data.
Regulatory Affairs Lifecycle Management ReALM® is a cloud-based platform supporting the regulatory value chain in the Life Sciences industry. Key modules support the streamlining of upstream activities, such as regulatory strategy and submissions planning, and downstream activities, such as registration tracking and health authority interactions, including the ability to integrate with other enterprise or cloud applications.
The ReALM® platform is:
- Powered by Microsoft technologies on Windows Azure
- A cloud-first RIM application designed for easy scale up
ReALM® comes with four key modules:
- ReALM® Regulatory Intelligence to streamline management of actionable regulatory intelligence.
- ReALM® Submissions Planning solution that enables country level and dossier table of content planning.
- ReALM® Registrations to streamline product registration, site registration and pre-registration management.
- ReALM® Interactions to capture and manage queries, correspondence and commitments with health authorities worldwide.
- Integrated global RIM process.
- Maintain data quality and compliance.
Orion Regulatory Affairs Lifecycle Management (ReALM®) Features
Enterprise Content Management Features
- Supported: Content capture & imaging
- Supported: File sync, storage & archiving
- Supported: Document management
- Supported: Records management
- Supported: Content search & retrieval
- Supported: Enterprise content collaboration
- Supported: Content publishing & creation
- Supported: Security, risk management & information governance
- Supported: Automated workflows
- Supported: Integration
Orion Regulatory Affairs Lifecycle Management (ReALM®) Video
Orion Regulatory Affairs Lifecycle Management (ReALM®) Integrations
- OpenText Content Suite Platform
- Microsoft Azure
- Clarivate
- Veeva Regulatory
- Mircosoft office 365
Orion Regulatory Affairs Lifecycle Management (ReALM®) Competitors
- Ennov Document Management
- Aris Global
- Generis
Orion Regulatory Affairs Lifecycle Management (ReALM®) Technical Details
Deployment Types | Software as a Service (SaaS), Cloud, or Web-Based |
---|---|
Operating Systems | Unspecified |
Mobile Application | No |
Supported Countries | United States, United Kingdom, Russia, Switzerland, Germany, India, Turkey |
Supported Languages | English |