Global Regulatory Advisory Service

Event-driven Insights, Opinions and Analysis from Experts on the Evolving Pharmaceutical Regulatory Environment

The Regulatory Advisory Service from Decision Resources and InnerVation Health provides unprecedented access to regulatory thought-leaders and their insight and analysis of the rapidly evolving regulatory environment for commercially important drug markets.

The service is the first and only advisory service to feature a proprietary panel of regulatory advisors including (former FDA and EMA directors, medical officers and current consultants) that offer their immediate and long term opinions and insights on events and critical shifts regarding regulatory issues for a variety of significant drug markets. There are three key components of the advisory service:

Regulatory Surveillance – The proprietary panel of regulatory experts continuously surveys the regulatory environment for the publishing of new clinical data, policy changes and other regulatory events that will impact a drug market. When an event happens, the panel is immediately engaged to provide their opinion and analysis on the topic.

Regulatory Insights & Perspectives – Panel members delve into controversial or open-ended issues that are influencing regulatory decisions and offer their analysis and perspective. This deep-dive analysis gives color to complex decisions or issues that may incite differing opinions. Listening to the conversations and debate of the panel will enable you to get into the mindset of the panel to validate your own analysis or provide an alternative opinion.

Regulatory Best Practices – The panel will routinely comment on best practices – especially as they continue to change. Safety, clinical trial design and post marketing are just a few topics that the panel will explore and give best practice opinions on. Future recommendations from the panel members based on past issues can make an immediate impact on your regulatory plans.

All three components of the service, Surveillance, Insights & Perspectives and Best Practices, will focus on the following areas:

• Preclinical/toxicology
• Efficacy
• Safety
• REMS
• Post marketing
• Clinical trial design
• Key drug class analysis

The Regulatory Advisory Service is delivered through the use of event-driven panel calls, research notes, and scheduled in-depth round-table discussions. All calls, both pre-scheduled and event-driven, are recorded so clients can attend live or listen to the recording at a more convenient time.