KLA Breakthrough

Regulatory Strategists Specializing In Rare Diseases

Regulatory strategists specializing in challenging orphan drug designation and pediatric rare disease cases, known for building the most solid arguments possible for therapies or indications that aren’t initially seen as easy wins.

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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.


A consultation during in vitro or pre-clinical stages will help you get the most out of your animal studies.

Find out how we can help!

KnowledgeWe understand how to get the special designations that attract investors and how to communicate with the FDA to keep your development plan on track.DedicationWe focus on the details of your development program to ensure a smooth path to ODD, Fast Track, RMAT, and Breakthrough designations.ServiceAlmost 90% of our contracts are return clients or referrals. The KLA team is honored to have earned the trust of so many pharma and biologic companies in the very competitive environment of drug development.


Across 6 continents

Providing critical support services to global pharmaceutical, biotechnology, and medical device clients across 6 continents.

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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.

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