This Is What You Need to Know About Regulatory Intelligence

When it comes to regulatory intelligence, change is the only constant. Yet keeping up is more complicated than it seems for many organizations, especially in pharmaceutical industry. Read this article to explore what businesses need to know about regulatory intelligence to stay ahead of trends.

Regulatory intelligence is a process through which organizations collect and analyze information about regulatory developments that may impact their business. Regulatory intelligence aims to help organizations make informed decisions on how to comply with regulatory requirements and protect their interests.

Approaches to Regulatory Intelligence

Regulatory intelligence professionals use two primary approaches to collect, analyze, and disseminate information – passive and active.

The passive approach focuses on observing, analyzing, and disseminating publicly known information. This approach can usually be achieved fairly quickly, and analysts do not need special expertise or access to sensitive information. Passive methods are well suited to detecting general and broad market trends and potentially important developments (e.g., new regulations, historic filings of regulations, etc.).

The active approach identifies and collects information about a person, company, or group. This approach is useful when an organizational unit needs to be aware of a critical event or event that could affect an important organization or seek to obtain certain information on a target. The approach involves:

  • Determining people who have valuable contacts.
  • Arranging information interviews.
  • Acquiring documents that are considered to be secret.
  • Negotiating with secret sources.
  • Monitoring activity.

Roles of Regulatory Intelligence in the Pharmaceutical Industry

Having an understanding of regulations helps companies to become more profitable. It enables businesses to anticipate and manage changes in regulations and trends and also to manage compliance more efficiently. It quickly spots and eliminates high-risk activities and avoids costly fines. It helps companies be more profitable by enabling them to respond faster to market demands, which translates into better customer outcomes and more revenue. It gives businesses good knowledge to make smarter decisions and react quickly to changing market requirements.

Having updated knowledge allows an organization to effectively address market, regulatory, and market-driven challenges cost-effectively and efficiently. Suppose you have a trusted analyst team that can quickly deliver information; you can quickly identify data points, determine sources, use monitoring platforms, and keep track of changes to laws that are relevant to your business.

Closing thoughts

Regulatory intelligence is critical to the governance, risk, and compliance cycle. When changes occur suddenly, having regulatory intelligence is critical to ensuring that you are prepared to handle them.

Plus, taking steps to protect yourself against compliance risks can help you position yourself as a market leader and allow you to take control of the market. So, keep regulatory intelligence a core component of your business intelligence to stay ahead of industry trends and remain competitive.

Stay up-to-date with changes in GMP requirements, annexes, and the new regulations that substitute EU directives by joining our latest webinar on 13th December 2022 :

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