Orphan Drug Designations (ODD) and Pediatric Rare Disease Vouchers (PRD)

At KLA-BC, we’ve decided that helping companies succeed in Orphan Drug Designations (ODD) and Pediatric Rare Disease Vouchers (PRD) is critically important.  Companies that are working to help patients who often have nowhere to turn deserve all the help they can get.  That’s why we’ve built specialized capabilities in the ODD & PRD space.  You won’t find a partner who understands your situation better.

Working in close partnership with our clients to improve the health and safety of patients, our global teams are committed to quality and excellence in everything we do to support clients throughout the full product lifecycle.

Kelly Austin


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Leverage Their Experience


Kelly Austin, founder of KLA Breakthrough Consulting, has over five years of specialization in rare diseases as a regulatory affairs partner to drug and biologic researchers.


Expect Focused Dedication


Kelly and the team at KLA Breakthrough Consulting bring a focus on excellence to their work in regulatory affairs. We see through the lens of experience in the rare disease space, and can tailor a plan to your team’s individual needs.


Assurance on Confidentiality


KLA Breakthrough Consulting has a long record of satisfied research scientists and pharmaceutical companies who continue to refer KLA to others. 90% of this year’s projects are from referrals or repeat clients.


Looking to Ensure Regulatory and Development Success Throughout the Lifespan of Your Product?

Contact us to learn more about how we can help you at every step of the product development lifecycle to improve patient health and safety.

Interested in gaining an industry edge? Let us help you stay current.