Your company possess unique expertise in your product. It is however critical to clearly shape your story, not only the data but also the program, goals, and risk management commitments. We can empower you to articulate the narrative behind your data and give you the tools you need to present it with confidence.
Prepare to win
Preparing to present and defend your product at a high stakes meeting is a major challenge for any team, your product’s future may be at stake. Achieving success in these venues requires a clear strategy and focused preparation. Your company needs to deliver a clear and compelling argument supporting your position and be ready to respond confidently when challenged. Our team combines a deep understanding of scientific and regulatory audiences and a mastery of communications tools and techniques to prepare you for key interactions with the FDA, EMA and other authorities worldwide. Our proven approach to preparation along with customized tools and techniques have helped client teams excel in many settings.
During a high stakes meeting, you have one chance to confidently present and defend your benefit/risk argument, resolve any concerns and communicate the value of your product. At NDA, we can support you in every element of meeting preparation – strategy, messaging, briefing materials and presentation development, Q&A and presentation skills training. You will understand how to address strategic and data challenges, how to make the complex simple and how to deliver an argument with impact to give your product the best possible chance for success.
If you need realistic and predictive mock panel sessions, we can offer panel members from our Advisory Board and our wide network of experts. These mock panels provide candid and actionable feedback to strengthen the communication skills of your team.
Just bring your data
You know your data, we help you deliver clear, concise and compelling messages at every point along the product lifecycle. NDA has successfully prepared hundreds of client teams for high-stakes interactions with regulatory bodies, payers and assessors using PharmApprove’s proprietary techniques in small groups, customized large workshops and private coaching sessions. Our experience spans all types of high-stake meetings, including Oral Explanations, Advisory Committees, HTA and payer meetings, pre-NDA/BLA meetings and PRAC Public Hearings.
Success favours the prepared. No matter how high the stakes are, we will ensure that you are in the strongest position possible to perform with confidence and integrity.
Our services include
- Pre-IND Meeting
- Oral Explanations/ SAG
- Advisory Committee Meeting
- PRAC Public Hearing
- Value Communication and Negotiation Training
- Facilitation, Presenting, Q&A Workshops
- Mock Panels
- Medical Science Liaison Workshops
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
Let's Bring Medicines to the World