Additional Services
Helping deliver the full potential of your data and your team.
BOLDAPPROVALS’ scientific and communication experts can help you with submission messaging, FDA meetings, and label workshops.
Submission Messaging
01 DEFINE OUTCOMES
Our approach to submission messaging begins by aligning your team around realistic, data-driven outcomes using our proprietary strategy tool, The Pointer.
02 AUDIENCE ANALYSIS
We analyze your reviewers through a rigorous assessment of interactions to date with the division(s). The goal is to anticipate any issues and concerns and apply review principles.
03 DEVELOP ARGUMENT
We help develop a persuasive, evidence-based argument to drive the review toward your desired outcomes.
04 MESSAGING
Our communication and scientific teams draft initial messages for each subsection of the Clinical and Nonclinical Overviews. The sponsor team then evolves and ratifies the messages in a specialized workshop using our propriety tool, The Framework.
FDA Meetings
Our team helps clients prepare for interactions with the FDA, Type A, B, C, and D meetings, including End of Phase 2 (EoP2), Pre-NDA, Pre-BLA, Application Orientation (AOM), and Mid-Cycle, and Late-Cycle Meetings.
DEFINE GOALS
Our approach to FDA meetings begins by aligning your team around a set of realistic, evidence-based outcomes using our proprietary strategy tool, The Pointer.
AUDIENCE ANALYSIS
We analyze the audience through a careful review of interactions to date with the division(s) and an understanding of the FDA participants. The goal is to anticipate any issues and concerns to help focus the communication strategy.
DEVELOP ARGUMENT
We guide the team in building an evidence-based argument to drive the meeting toward the desired outcomes.
MESSAGING
Our communication and scientific teams draft initial messages for the slide deck and briefing document. The sponsor team evolves and ratifies the messages in a specialized workshop using our propriety tool, The Framework.
CONTENT DEVELOPMENT
Our writers draft the briefing document while, in parallel, our scientific and communication team works closely with the sponsor’s internal and external experts to develop the presentation and Q&A. As these evolve, our slide team prepares all presentation and Q&A slides.
DELIVERY COACHING
Our individual and team coaching refines both delivery and content. Rehearsals ensure that the right expert participates at the right time and under the direction of the meeting leader. We ensure everyone knows when to speak and when to remain silent with a neutral facial expression.
PRODUCTION AND LOGISTICAL SUPPORT
We offer complete logistical, technical, and project management support to ensure your meeting, whether in-person or virtual, runs seamlessly.
Label Workshops
The BOLDAPPROVALS team offers complete support, from assessing the current landscape and reviewing your Target Product Profile (TPP) to engaging stakeholders within a label optimization workshop.
Label planning is not a one-time exercise. We can revisit your label strategy periodically to review against new data and an evolving landscape during clinical development and again prior to submission.