When it comes to navigating the complexities of FDA regulations, the stakes are incredibly high and the margin for error is slim.

Choosing the right partner can make all the difference.

At KLA Breakthrough Consulting, we specialize in navigating the intricate landscape of FDA regulations to ensure the most efficient path to market. 

We craft individual regulatory strategies designed to result in Accelerated Approval. Early on, for our clients with rare disease indications, we secure crucial designations like Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD). We also help determine whether an INTERACT meeting is appropriate, and which questions are most likely to result in an FDA response. As your therapeutic moves closer to clinical trials, we provide GAP analyses and Pre-IND meetings, as well as INDs and eCTD publishing services. We specialize in Fast Track, RMAT, and Breakthrough designations for drug developers, which enable the most efficient path to NDA/BLA and marketing approval.

Boasting an industry-leading success rate of over 95% on ODD and RPD, our approach starts with a meticulous pre-contract data analysis, followed by a tailor-made strategy to meet each Sponsor’s unique needs. 

Our mission is to be more than just consultants; we aim to be dedicated partners in giving your therapeutic its best chance for fast, efficient FDA approval. 

Driven by an unwavering commitment to both scientific rigor and client relationships, we offer transparent, collaborative, and personalized services that set us apart in the industry.

► 700+ FDA Submissions

► 300+ FDA Orphan Drug Requests

► 100+ FDA Pediatric Rare Disease Applications

► 50+ Fast Track, Breakthrough, RMAT

KLA Breakthrough Consulting

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