Regulatory Affairs Lifecycle Management (ReALM®)

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Orion Innovation is a leading digital transformation and product development services firm. Headquartered in Edison, NJ, we have a global team of over 6000 associates, with engineers in 13 major delivery centers spread across the Americas, Europe, and APAC. For over 25 years, Orion has been solving complex business problems for our clients. Our transformative business solutions are rooted in digital strategy, experience design, and engineering, empowering our clients to operate with agility at scale. Orion has been serving the pharma and life sciences industry with business solutions for over a decade. We help companies harness data in impactful ways to achieve business outcomes. We provide software solutions and services in areas that have traditionally been slow to exploit the power of data. Regulatory Affairs Lifecycle Management (ReALM®) is a cloud-based platform that transforms 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. - Flexible, configurable and easily deployed to address client-specific needs. - 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. ReALM® Benefits: - Enables quick onboarding, configuration and deployment. - Increases efficiencies, and reduces cycle time and rework. - Integrated global RIM process. - Maintain data quality and compliance.