simplifying fda approvals
amplifying
success
Navigate regulatory complexity to give your therapy
the best chance for market success
Regulatory Strategy Development:
Crafting individualized plans to achieve Accelerated Approval, Fast Track, Breakthrough Therapy, and RMAT designations.
FDA Engagement:
Assisting clients in securing ODD and RPD designations early in development, determining the appropriateness of INTERACT meetings, and formulating questions likely to elicit FDA responses.
Clinical Trial Support:
Providing GAP analyses, Pre-IND meeting preparations, IND submissions, and eCTD publishing services as therapeutics progress toward clinical trials.
Navigate Regulatory Complexity
simplifying fda approvals
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 partnership
We value long-term relationships over quick transactions. Our personalized, boutique approach ensures you’re more than just a client – you’re a partner.
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.
Accelerate 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 Pedriatric Disease
Qualify for a priority review voucher that sells for $100,000,000 on the open market.
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.
Serving Global Clients
KLA Breakthrough Consulting partners with innovators around the world to accelerate rare disease and unmet need drug development.
With clients across North America, Europe, Asia-Pacific, and beyond, we provide regulatory expertise and personalized support no matter where you are.
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.