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 around regulatory strategy, submission planning and registration tracking, including the ability to integrate with downstream activities and applications.
The ReALM® platform is:
- Powered by Microsoft technologies on Windows Azure
- Flexible, configurable and easily deployed to address specific client needs
- A cloud-first application designed for easy scale up
How it Works
ReALM® comes with two key modules:
- Global Regulatory Intelligence and Planning (GRIP) to streamline management of actionable regulatory intelligence and submissions planning; and
- Registration Tracking System (RTS) to streamline product registration management and interactions with health authorities worldwide.
GRIP allows for management of curated regulatory requirements (both hard and soft intelligence) in actionable ways through a master library of global requirements that are available as checklists for various regulatory and submission activities. These checklists can then be leveraged for understanding regulatory requirements, like preparing a clinical trial application or creating an NDA submission for a group of countries. These predefined checklists are based on health authority requirements and can be further modified by a regulatory strategist for a specific product based on product strategy and negotiations with respective health authorities. Made available as detailed plans with country regulations in mind, you can assign deliverables to different individuals for fulfilling the requirements. GRIP comes with web services which allows integration to downstream applications, such as document management and submission publishing.
RTS allows the management of product registration information for various markets and related health authority interactions, such as correspondence or requests for information or commitments. RTS comes with web services which allows integration to upstream applications such as document management and submission publishing.
- Master library of global regulatory requirements managed by curators
- Standard templates of requirements for different types of submissions and regulatory activities
- Structured, table-of-contents to manage regulatory requirements and intelligence unlike other unstructured sources commercially available in the market
- Access to subject matter expertise and interpretations of guidelines and experiences from across the globe
- Links to external health authority guidelines, forms and other publicly available sources
- Creation of product/country specific submission checklists and plans
- Creation of master plans and Gantt charts of submissions from requirements templates with activities, task assignments, milestone dates and deliverables
- Ability to track completion of submission planning activities and assignments
- Ability to track variances between baseline plans and changed plans with audit trails
- Dashboard of submission checklists, plans and status by country, by submission type, etc.
- Integration with downstream document management and submission publishing applications
- Increase efficiencies around regulatory strategy and submission planning activities
- Access updated, high-quality regulatory requirements and local interpretations
- Convert requirements to actionable checklists and submission plans
- Increase speed to market
- Reduce cycle time/rework by 25%
- Reduce ownership of multiple, incompatible tools and systems
- Increase content reuse and minimize differences in filing strategy
- IDMP-ready product master definition and inclusion of controlled vocabularies for most data elements
- Ability to manage product registration information and approved labels
- Tracking of health authority interactions (correspondence, requests and commitments)
- Ability to search on various characteristics of product registrations
- Ability to manage life cycle including variations, amendments, etc.
- Dashboard of submission plans, product registrations
- Integration with upstream document management and submission publishing applications
- Distribute ownership of product registrations and approvals at the country level, regional level and headquarters level
- Provide visibility to up to date product life cycle information and approval status
- Central repository of health authority interactions and company responses
Learn more about our cloud-based services.