Regulatory Intelligence

Regulatory Readiness: Overview

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by

Irina Saavedra
in

1. Essential Framework for Regulatory Readiness 

To build a sustainable readiness program, organizations should adopt a life-cycle approach: 

  • Regulatory Intelligence: Establish a formal “Intelligence-to-Action” process to sense and track upcoming legislative changes.
  • Risk Assessment: Develop a framework to prioritize risks and allocate resources based on potential impact.
  • Standardized Policies: Implement global, standardized policies that provide a consistent compliance baseline while allowing for regional nuances like data protection (e.g., GDPR). 

2. Core Pillars of Preparation

The most effective readiness plans include these actionable components: 

  • Documentation & Record-Keeping: Maintain an organized, centralized digital repository of Standard Operating Procedures (SOPs), training records, and validation logs.
  • Cross-Functional Teams: Appoint a dedicated compliance team and clear owners for specific tasks to ensure accountability.
  • Training and Education: Conduct regular, scenario-based training for employees and new managers to ensure they understand their specific compliance roles.
  • Mock Inspections: Simulate real regulatory audits to identify gaps, practice interview protocols, and build team confidence. 

3. Strategic Best Practices for 2025

  • Leverage AI and Automation: Use AI-driven tools for data extraction, medical writing, and submission planning to improve speed and accuracy.
  • Focus on Culture: Foster a “Culture of Compliance” where staff are not afraid to speak up when errors occur, enabling faster corrective actions (CAPA).
  • Advanced Metrics: Track Key Performance Indicators (KPIs) such as the percentage of filings submitted on time and the number of internal audit gaps addressed. 

4. Key Industry-Specific Resources

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