What We Do
Leveraging our expertise in regulatory strategy, cutting-edge science and communications, we help you deliver clear, concise and compelling messages at every point along the product lifecycle.
We will bring out the best in your team to drive better outcomes
Everyone knows data never speaks for itself. How do you confidently present and defend your benefit/risk argument when the science is complicated and the clinical picture is subject to interpretation? That’s where we come in.
We help create a persuasive narrative that can be communicated to and understood by the stakeholders who matter the most. We begin by identifying the big issues, to build your story from a strong scientific foundation into a meaningful message.
What we do
Drive better decisions – and outcomes
We align your team to a shared narrative and prepare them for high-stakes interactions – with regulators, advisors, and the public. Our flagship services span 20 years of successful FDA Advisory Committee meetings in the US and EMA Oral Explanations (OE) in Europe.
While these are the most pivotal occasions on the path to approval, we also help you drive better decisions internally, leverage dialogue with all stakeholders, and achieve better outcomes for you and the patients you serve.
Advisory Committee Preparation
No regulatory event is as intense as an FDA Advisory Committee meeting. For some, it can decide the fate of the product and the company. You need a partner who has been in your shoes and objectively interprets the science, regulatory environment. We quickly assess the issues and challenges of your program and excel at bringing out the best of your team.
Oral Explanation (OE)
In Europe, the Oral Explanation is a pivotal opportunity to make your case in front of the scientific committee (CHMP) of the EMA. The CHMP may also call a Scientific Advice Group (SAG) or Ad Hoc Expert Group (AHEG) to get key insights from practitioners and experts in the therapeutic area. Knowing how the regulators reason, what they need to hear and see, and how best to prepare for these different audiences is our specialty.
Scientific Advisory Boards
A crucial part of commercial success is communicating clearly and persuasively – no matter your audience. Regulators, payers, investors, clinicians and other stakeholders have questions about the value of your product and its place in therapy. We help you communicate internally and increase productivity and strategic alignment on messaging. We empower you to articulate the story behind your data and give you the tools you need to defend it with confidence.