ReALM® Regulatory Intelligence module allows for the 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. Regulatory intelligence includes a layered approach including collection and management of policies, regulations, guidelines, subject matter interpretations, best practices, and company experiences or prior knowledge.
Regulatory requirements can be applied to create checklists for specific products and activities, for example, preparing a clinical trial application or creating 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.
Key Features:
- Master library of global regulatory requirements managed by curators.
- Standard templates of requirements for different types regulatory and submission activities.
- Structured table-of-contents to manage regulatory requirements and intelligence.
- Layering of subject matter expertise, interpretations of global regulations/guidelines, best practices and company experiences from across the globe.
- 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.
Benefits:
- Increase efficiencies around regulatory strategy and submissions activities.
- Access updated, high-quality regulatory requirements and local interpretations.
- Cater to multiple stakeholders – regulatory strategists, regulatory operations, CMC, labeling, etc.
- 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.