Applied Regulatory Consulting

The pharmaceutical regulatory framework is complex and continues to grow more so day by day. The innovation of new technologies and product types, the on-going harmonisation of regulatory requirements, together with the growing number of countries in the EU, have all contributed to an environment where it is becoming increasingly hard to predict how the regulatory agencies will view applications for clinical trials and marketing authorisations.

At the same time more and more information is becoming available, much of it in the public domain. Recent transparency initiatives mean this trend goes on accelerating. Consequently it is becoming increasingly important to know how to find this information, filter it and analyse it in ways that can help to more accurately predict and manage the expectations of regulatory agencies, at a national, regional and global level.

What is regulatory intelligence?

The scope of regulatory intelligence is extensive and is considered to comprise the aggregation of numerous data sources, followed by appropriate analysis, filtering and interpretation to produce a range of defined outputs, which include regulatory strategy, impact assessments and relevant dissemination of key information to everyone involved in making decisions with respect to current and future products. Furthermore this process is iterative as the regulatory environment is constantly changing.

• Regulatory information - For effective regulatory intelligence it is critical to gather data from all of the relevant information sources. This includes information published on regulatory agency web sites, as well as information from other sources such as meeting notes, conference presentations, literature and corporate history. Such data may be published or unpublished. It may have been shared verbally or in writing. Sources can also include searches and competitor experiences. The importance of networking must also be understood and used effectively to add further information.
• Regulatory analysis - The extent of the regulatory information available is considerable and is expanding and changing at an increasing rate. This means it is essential to be able to effectively filter and compare information to determine patterns and precedents, and interpret these with a full understanding of the context. The rate of change also demands consideration of trends. All of these analyses need to be focussed to the specific products and development projects under consideration.
• Regulatory strategy - The output of the analyses of the regulatory information must be disseminated in effective ways to influence the development of products and optimise the chances of commercial success. This will involve the preparation of product-specific strategies as well as broader impact assessments and must provide a vehicle for continual updating.

How can we help you with your regulatory intelligence?

Our principal consultant Tim Felgate is the creator of reg-info.com, a resource which has been serving the regulatory community for the past 15 years. He is also set up TOPRA’s Regulatory Intelligence Special Interest Network (SPIN) in 2010, of which he is also the Chair.

We have developed a number of techniques for gathering and analysing regulatory information, which we can apply to your product development. From these we can provide you with regulatory strategies which are based on a detailed analysis of the available regulatory information. Furthermore we can provide you with continual updates, delivered according to your needs (e.g newsletters, RSS feeds and digests).

If you are considering establishing your own in-house regulatory intelligence capabilities, we can guide you in how this can best be achieved. We can conduct workshops with your staff to enable the key concepts and their translation into practice to be fully understood.

If you would like help with any of the above, or would like further information, please contact us.