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.

The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).

AdComm
Preparation

Additional
Services

Approvals Team
Experience