Accessing reference products for bioequivalence and development programs can present strategic and regulatory challenges, particularly when products are subject to restricted distribution or limited availability.

Specialty PharmaSource provides comparator strategy consulting to assess sourcing pathways, batch selection, market selection, and supply risk mitigation. When necessary, we support access approaches aligned with the CREATES Act to facilitate procurement of reference products for development and regulatory submission.

Effective comparator strategy is not simply procurement—it is a regulatory and timeline decision that can shape the success of the entire program.