Accelerated Regulatory Pathways (BTD, PRIME, Fast-Track…)

As part of our regulatory services, the Alira Health team can:

Analyze if your product plan qualifies for a regulatory expedited pathway.
Assist in requesting and applying for:
FDA Expedited pathways including Breakthrough Designation, Fast-Track Designation, Accelerated Approval and Priority Review.
EMA Expedited pathways including PRIME Designation, Accelerated Assessment.