KLA Breakthrough Consulting

Simplifying FDA Approvals Amplifying Success

Customized Strategies and Comprehensive Support to Quickly Achieve Milestones

We help you design a strategy, then apply it to every engagement with the Agency. Successfully open your IND, start your next clinical trial, and submit your marketing application as quickly as possible.

Obtain a streamlined path for therapies promising substantial improvements over existing treatments. We craft your accelerated approval designation application, focusing on the evidence to meet FDA requirements.

We provide FDA communications based on your comprehensive development strategy. Meet your milestones more quickly with questions designed to engage the FDA and get answers on your key issues.

Let us submit your FDA correspondence through the ESG gateway, saving time and money.

Secure incentives and garner investor interest for therapeutics treating rare diseases.

Qualify for a priority review voucher that sells for $100,000,000 on the open market.

At KLA Breakthrough Consulting, we specialize in navigating the intricate landscape of FDA regulations to ensure the most efficient path to market. Early on, we secure crucial designations like Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for our clients. 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%, 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.

A 95% industry-best success rate doesn’t happen by accident. It’s the result of meticulous planning, deep expertise, and a client-centric approach.

Our scientific and regulatory acumen is second to none. With our deep understanding of both written and unwritten FDA rules, you’re always one step ahead!

We value long-term relationships over quick transactions. Our personalized, boutique approach ensures you’re more than just a client – you’re a partner.

Ready for a Breakthrough Success?

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