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Regulatory Intelligence — a corner stone in Regulatory Affairs

When working in Regulatory Affairs (RA), you must continuously be on your toes! In an ever-changing regulatory landscape, numerous regulatory recommendations/directives/guidelines, continuous amendments/updates and the various sources required to locate them might appear overwhelming and complicated. You may ask yourself; how should you proceed when a new regulatory trend is observed, or when agencies send out guidelines for review or publish a finalised enforcing version? How should a life science company prepare for upcoming changes, and how do you ensure timely review of guidelines? How can the impact of the changes be assessed? How can you determine which stakeholders to involve and in what way? How do you ensure a slim and transparent, yet efficient process, from start to end? The answer to all these questions is simple; by utilising Regulatory Intelligence (RI).

Regulatory Intelligence staff — not just “hunting dogs”

The interpretation of RI is not as simple as it may sound, as numerous definitions of the term exist. For the purpose of this blog post, RI should be considered rather broadly, referring to both the considerable bunch of global and local Regulatory information being discussed and drafted by agencies and the actions taken to capture and analyze it accordingly.

Figure 1. Obtaining and handling Regulatory Intelligence in Regulatory Affairs

Tools for Regulatory Intelligence

But how and where can “prey” be located? How should it be anchored in the organisation, e.g. RI data and documents?

About the author — Mette Leth Schousboe, PhD, Senior Regulatory Lead

Regulatory Consultant with passion for life science, patient centricity, and stakeholder management. Mette has extensive knowledge from the pharmaceutical industry, both within global and local Regulatory Affairs, working with several aspects of Regulatory Affairs and Pharmacovigilance, e.g. clinical trials, developing products, life cycle management, labelling, and pharmacovigilance compliance. As regulatory SME, Mette has strong competences in RA business process optimisation and implementation.

About BASE life science

BASE life science is an innovative and forward-thinking technology, product and service consultancy specialised in creating real business value from digital platforms and data. Our experienced teams are ready to help optimise your technology and business processes within Customer Engagement, Quality, Regulatory, Compliance and Clinical data management.

BASE life science is a fast growing, fast paced consultancy focused on the life science industry.

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