Our ReALM® GRIP Solution

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Our ReALM Global Regulatory Intelligence and Planning (GRIP) is a set of Cloud-based solutions providing a structured and repeatable process to access regulatory guidelines, subject matter interpretations and industry best practices for different types of regulatory activities and submissions across the globe along with the ability to create actionable component-level plans using standardized templates. The ability to go from regulatory strategy to checklists to actionable plans is unique to ReALM, which existing solutions do not address today. We strongly believe that access to regulations, templates and plans all in a single, subscription-based solution greatly improves efficiencies and reduces total cost of ownership due to the availability of all strategy and planning related items in one repository. We would be glad to arrange for a demo. Please send us a request to realmdemo@cabeus.com.

Regulatory Strategy and Planning activities in pharmaceuticals and medical device companies are currently made of a number of disjointed sets of tasks using spreadsheets or siloed technology capabilities, introducing a number of inefficiencies during the upstream phases of the regulatory value chain, resulting in downstream delays, significant re-work, missed opportunities and potential loss of revenues.

Regulatory
Intelligence

Regulatory Submission

Planning

Enable regulatory strategy and planning activities by providing an integrated, authoritative, globally accessible, reference repository of regulatory requirements to enable effective submissions planning:

  • Lightweight planning capability, easy to use
  • Assign team members to tasks
  • Create project schedules
  • Export to MS-Project or Excel

 

  • Global repository of regulatory requirements
  • Requirements checklist generation
  • Submissions planning and preparation

 

Schedule a Demo

  • Regulatory Requirements
  • Submissions Requirements
    (INDs, NDAs, BLAs, PSUR/DSUR, GVD, others.)
  • Submission review
  • Lifecycle Management Requirements
  • Inspection, Labeling Stability Requirements
  • Subject Matter Expertise/Industry Best Practices
  • Company Specific Experiences
  • High-Level Checklists/Granular Requirements
  • Cross-Sectional Views of Requirements
  • Submission Publishing Templates
  • Submissions Planning

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