KLA Breakthrough Consulting

Navigate Regulatory Complexity to Give Your
Therapy the Best Chance for Market Success Simplifying FDA Approvals

Amplifying Success

95% Success Rate

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.

Unequaled Expertise

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!

Genuine Partnerships

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

WHAT WE DO

Your Trusted Partner on the Pathway to
FDA Marketing Approval

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.
HOW WE DO IT

Regulatory Expertise Tailored for Your
Success

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.
Tailored Solutions for Sponsors

Customized Strategies and Comprehensive Support to Quickly Achieve Milestones

Strategic Consulting
IND, Trials, NDA/BLA

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.

Accelerated Approval (Fast
Track, Breakthrough)

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.

FDA Meetings
(INTERACT, Type A/B/C/D)

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.

In-House eCTD
Publishing

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

Orphan Drug Designation

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

Rare Pediatric Disease

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

Why Choose

KLA Breakthrough Consulting

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.

Ready for a Breakthrough Success?

Taking the first step toward FDA approval can be daunting, but you don’t have to go it alone. At KLA Breakthrough Consulting, we’re here to guide you through every phase of the journey, from initial consultation to marketing approval.