This is for consulting services for Senior Staff.

Investigators

Abstract

Non-Clinical Development consultants will provide leadership in support of the full process of product development for regulatory approval for NIH biologics programs. Consultants will be asked to provide guidance on IND-enabling studies to ensure that teams meet the guidelines and timelines of IND applications. Consultants will serve as the principal regulatory contact with NIH staff, PIs, and regulatory agencies, and may also be the primary regulatory representative to the FDA.