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AdComm Audience Analysis

Our proprietary AdComm Audience Analysis provides powerful insights on the committee as a whole and each member, including voting analytics and behavioral assessment.

BOLDAPPROVALS Team Experience

The Approvals team has supported more than 250 unique preparations for FDA Advisory Committee meetings, our highly experienced team is ready to help you at tackling complicated challenges and anticipating the strategies you need to succeed at the AdComm

Scientific Messaging & Content Development

Based on the Adcomm strategy, our communication and scientific teams can draft the scientific messages that drive the key deliverables and work closely with your internal and external experts to develop the briefing document, presentation, and Q&A.

Label Workshops

The BOLDAPPROVALS team offers complete support for label development, from assessing the current landscape and reviewing your Target Product Profile (TPP) to engaging stakeholders within a label optimization workshop.

FDA Submission Messaging

Our multidisciplinary approach aligns your team around a communication strategy and data-driven messages designed to achieve your desired outcomes for the submission.

Our structured approach to FDA meeting preparation addresses strategy, scientific content, and delivery. We help clients prepare for a wide range of meetings, including End-of-Phase2 (EoP2), Pre-NDA/BLA, Application Orientation meetings (AOM), Mid-Cycle and Late-Cycle Meetings.

Contact us today to get help with your AdComm, Submission Messaging, FDA meetings, and Labeling Workshops.

Delivery Coaching

We coach your team to establish a strong, credible connection with the committee while delivering the presentation and responses to questions.

Content Refinement

We guide the iterative development of the content through ongoing engagement, supported by extensive rehearsals and carefully timed Mock Advisory Committee meetings.

AdComm Strategy

We begin with a communication strategy designed to deliver the specific outcomes you need, based on an in-depth understanding of your product and the Committee.

AdComm Tools & Technologies

Our cutting-edge tools and technologies are custom-built to support the needs of AdComm teams, including our fully digital slide calling and switching system.

The chance to improve patients’ lives starts with regulatory approval.

BOLDAPPROVALS helps you reach your approval goals with comprehensive multidisciplinary support for FDA Advisory Committee meeting preparation (AdComm prep), submission messaging for NDAs and BLAs, labeling strategy, and FDA meetings.

Our experienced communication and scientific team, coupled with our cutting-edge digital platform, can flexibly meet your needs with start-to-finish service and support.

AdComm
Preparation

Additional
Services

Approvals Team
Experience