ReALM® Regulatory Intelligence allows for management of curated regulatory requirements (both hard and soft intelligence) in actionable ways through a master library of global requirements. The library is made available in checklist format for various regulatory and submission activities.
The checklists can then be leveraged for understanding regulatory requirements, like how to prepare a clinical trial application or create an NDA submission for a specific country. These predefined checklists are based on health authority requirements and can be further modified by a regulatory strategist for specific products based on product strategy and negotiations with respective health authorities.
- 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.
- Access to subject matter expertise and interpretations of global guidelines and experiences.
- Links to external health authority guidelines, forms and other publicly available sources.
- Creation of product/country specific submission checklists.
- Dashboard of submission checklists and status by country, submission type, etc.
- Integration with downstream document management and submission publishing applications.
- Increase efficiencies around regulatory strategy and submissions activities.
- Access updated, high-quality regulatory requirements and local interpretations.
- Increase product development 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.
Learn more about other ReALM® modules here.