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About KLA Breakthrough Consulting

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.

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. KLA guides small teams from pre-clinical proof of concept studies through the bumps and turns along the road to drug development. KLA is here to smooth the path. They understand how to get the special designations that attract investors and how to communicate with the FDA to keep your development plan on track. Click here to schedule a free one hour consultation to discuss how we can help.

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. We focus on the details to maximize the chance of success at each step toward marketing approval. Whether it’s a request for an Orphan Drug Designation, a Pre-IND meeting, or a Breakthrough Designation, KLA knows what to look for, and look out for.

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. 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. KLA will continue to support each and every client with their significant and sensitive work.

Book a free consultation today and

learn what we can do for you.

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