High-stakes Meeting Preparation

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High-stakes Meeting Preparation

At critical lifecycle milestones, such as CHMP Oral Explanations, FDA Advisory Committee Meetings and payer negotiations your product’s future may be at stake. Preparing to present and defend your product at a meeting with decision-makers is a major challenge for any team. Achieving success with decision-makers 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.

At NDA we’ve brought together unmatched scientific, regulatory, payer as communication expertise to tailor a service that will give your team the best chance to prevail when engaging in high stakes meetings. Our proven approach, experienced teams and customised tools and techniques have helped hundreds of teams succeed since the late 1990s.

Today we focus our line of services on a number of critical milestone meetings ranging from FDA Advisory Committee Meetings and European Oral Explanations, to payer negotiation preparation. In addition, we create customized solutions to support all of your of health authority interactions and commercial milestone meetings.

FDA Advisory Committee Meeting Preparation Services

An FDA Advisory Committee meeting is one of the most intense and challenging regulatory events in the lifecycle of your product. Years of development may culminate in this very public and mission-critical challenge to make your most persuasive argument. There is only one chance to get it right. We help you succeed by using our proven approach to preparing your team to deliver with impact and confidence.

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Oral Explanation Preparation

Facing the CHMP at an Oral Explanation is an intense, time pressured exchange. When it comes to addressing
major objections to your Marketing Authorisation Application (MAA), well-crafted written responses may only be half the battle. If you’re called to an OE, we can help you to craft and deliver a concise and persuasive presentation and develop targeted, expert tested arguments to drive your Q&A responses.

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Payer Negotiation Preparation

Presenting your core value proposition to payers and HTA bodies is both challenging and stressful. We work with you to take this final step toward commercialisation by helping you shape your outcomes evidence into a persuasive case for reimbursement. We align your affiliates and then train your team to deliver and negotiate successfully.

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Other Milestone Meetings

PharmApprove’s industry-leading team of principals and senior communications strategists can help you address regulatory needs at every stage of development, including:

  • Pre-IND Meetings
  • EOP 2 Meetings
  • Scientific Advice (EMA)
  • Pre-NDA/BLA Meetings
  • NDA/BLA Submissions
  • Challenge Panels
  • Advisory Committee Preparation
  • Oral Explanation (CHMP)
  • Scientific Advisory Group (SAG)