Regulatory Intelligence

RI

Regulatory Intelligence

“Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. market research on a product, outlining risks and opportunities, etc – to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.

Companies operating globally & that are required to be compliant with New and existing legislation/guidelines whether local or regional, need to have a robust regulatory intelligence team which keeps guiding the company with the industry insights. These are Complex environment and are ever increasing changing in nature. It also helps in influencing future regulatory framework with supporting policy and advocacy activities.

Key responsibilities of a RI function

  • Rapidly identify and communicate significant changes in the regulatory environment to key internal stakeholders
  • Conduct and deliver unique and insightful analyses that facilitate strategic decision-making
  • Serve as internal regulatory consultants and respond to adhoc intelligence requests
  • Facilitate access to high-value and frequently referenced regulatory intelligence sources
  • Enable effective advocacy work through managing ‘one-voice’ commenting on draft regulatory authority documents



Overall benefits of RI activities

  • Identifying regulatory opportunities
  • Reduced time to market
  • Reduced development costs
  • Increased compliance



Challenges in RI function

  • Ever increasing growth of information
  • Regulatory Authority transparency initiatives
  • Regional differences - External regulatory environment across the globe
  • Information flow- reaching the right people in your company. Its about push versus pull of information.