Oral Explanation (OE)
When you have 20 minutes to resolve the regulators’ concerns, knowing their perspective is crucial.
Prepare to win
Your last chance to convince
You’ve faced objections. The case is not clear and the European experts are not convinced. The Oral Explanation is your last opportunity to resolve the regulators’ concerns.
We are the only consultancy that can lead you to success with our standing board of European ex-regulators, global regulatory and scientific experts, and communications strategists. We are the key to solving the puzzle, creating a convincing argument, and coaching your team to deliver effectively.
1515-year track record
100+CHMP Oral Explanations
20+Standing ex regulators
What we do
An Oral Explanation is a unique and difficult challenge. Time is limited, the topics focused, and the battle uphill. We can help.
Our standing NDA Advisory Board comprises former EU regulators, many who were instrumental in the construction of the existing regulations. This unique pool of experts reflects the current position and thinking of the CHMP better than anyone else. Together with our strategic communications specialists, we create powerful narratives, supported by your data, to increase your chance of success.
Whether you’re preparing for an OE, SAG or Ad Hoc Expert Group (AHEG), we work with your team to develop a solid response strategy and prepare you to deliver it in the most concise and compelling way possible. By testing your argument with our expert panels of EU representatives, you will receive actionable feedback and insights found nowhere else. This will enable you to refine your narrative, strengthen your defenses and ultimately lead you to success.
A professional focused team.
You prepared us for any possibility. Thank you!
EMA guidance on Oral Explanations
If you would like to learn more about Oral Explanations and how they fit into the regulatory framework in Europe we recommend a visit to EMA’s web page on the evaluation of medicines or the document Guidance to Oral Explanations.
We are ready to help you
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