Regulatory Meeting Support

Regulatory Meeting Support services offer support for regulatory presentations. The scientific and regulatory experts of PRO Consulting help sponsors prepare for, and if requested, accompany them to meetings with FDA review divisions or other regulatory bodies. When attending a meeting, the PRO Consulting role may vary from being a silent participant (responding only to specialty PRO questions) to actively presenting to FDA reviewers.

Accompany and support sponsor team at an FDA meeting
Can include a speaking or observational role at the meeting
The scope includes preparation of documents and, if appropriate, slides for the meeting
PRO consultant will attend preparation meetings and then the FDA meeting itself