Backed by Y CombinatorWe pair leading regulatory expertise with our custom software to deliver regulatory support, strategy, and full submissions with speed and rigor for life science teams.
Get focused support for a specific challenge or a partner to carry the work forward across your biotech or device program.
Clarify how your product is regulated, assess available pathways, and define your next steps.
Get answers to your outstanding regulatory and strategic questions.
Prepare meeting materials, engage strategically, and translate agency feedback into action.
Draft, assemble, and critically review submission packages, then anticipate and address questions during agency review.
We recently prepared a full pre-IND meeting request letter, package, question set, and supporting evidence, with strategy and review by a former FDA deputy division director, in one week.
Navigate ongoing obligations and assess the regulatory implications of product changes and new uses.
Lengthy drafting cycles, fragmented evidence, and issues discovered late can consume time your team needs elsewhere. We build our work around addressing these bottlenecks, from the first strategic question to the final review.
Pricing
Hourly billing incentivizes slow work
Preparation
Labor-intensive drafting and revision
Review
Error-prone manual document and evidence review
Pricing
Prices set and agreed to before the work starts
Preparation
Custom technology accelerates preparation
Review
Expert review supported by software that checks claims against evidence
Our software drafts from your source materials and checks every claim against the evidence behind it.
Nothing for your team to learn, license, or run, unless you want to. We operate it, you receive the deliverables.
Repeat-dose toxicology supports the proposed starting dose.
Source: 28-day GLP study report, section 9.2
The manufacturing process is controlled at the stated scale.
Source: Batch records, lots 004 to 011
Stability supports the proposed shelf life.
Gap: No source covers the final three months
Many programs benefit from collaboration with a recognized specialist in a specific discipline or agency division.
Our experience working with these experts lets us source the right one when it would benefit your program, and we never bring in a specialist without your agreement.
Many have reviewed submissions from inside the agency, so they know how yours will be read.
A recognized name signals a serious program to investors and reviewers.
Established, credible agency relationships help a review stay on track.
A focused read on pathway, positioning, or likely agency response.
A specialist review of the arguments and evidence before a package is filed.
Sustained participation through preparation, agency interaction, and review questions.
We discuss your program, existing materials, and immediate priorities, then agree on everything in writing before work begins.
We talk through your product, the materials you already have, and the priorities in front of you.
We create a written scope with deliverables, a timeline, and a price.
Our team delivers against that scope, and you always know what the work will cost.
Cascadium was founded to close the gap between how quickly life science teams can move and how quickly regulatory work gets done.
Chief Executive Officer
Michael leads Cascadium's scientific engagements. He came to regulatory work through computational drug discovery as an Emergent Ventures grantee, designing neural network architectures for modeling cell behavior, where the cost of slow regulatory cycles became impossible to ignore. Michael studied Cognitive Neuroscience and Chemistry at the University of Pennsylvania.
LinkedIn profile for Michael Konu
Chief Technology Officer
Harsha leads the development of Cascadium Intelligence, our proprietary software for sourcing up-to-date regulatory guidance and detecting errors in submission documents. He holds multiple degrees in machine learning from Georgia Tech, has built machine learning systems at Uber, Google, and Apple, and is a proud Eagle Scout.
LinkedIn profile for Harsha Karanth
Chief Product Officer
Steven is responsible for how our product accelerates experts' output of trustworthy services. At Datadog he built infrastructure management platforms that keep systems reliable for a customer list including all 10 of the largest AI companies. Steven studied computer science at Columbia as a National Merit Scholar, specializing in computer infrastructure for AI machine learning systems.
LinkedIn profile for Steven WinnickBoth. We prepare and assemble complete submission packages, and we also take focused pieces of work: a pathway question, a gap assessment, meeting materials, or a critical review of drafts your team has already written.
Yes. We are used to fitting into a program that is already running. We can own defined workstreams, strengthen work in progress, and coordinate with the consultants and partners you already rely on.
Not automatically. Whether a specialist would change your outcome depends on your product, pathway, and the specific challenge. We tell you when we think one would help and why, and if you would rather keep the work in-house, our team delivers it.
It depends on the scope and on how complete your source materials are. Work that commonly takes weeks or months can often be delivered in hours or days, and we commit to a timeline before the work starts.
Our software accelerates drafting and checks how well each claim in a document is supported by your source materials. It adds a layer of error checking on top of expert review rather than replacing it, and our regulatory team reviews everything before it reaches you.
We agree on scope, deliverables, timeline, and price before work begins. There is no hourly billing, so the cost does not grow with the hours spent.
A submission date, an agency meeting, a pathway question, or a package that needs a hard review. We’ll tell you what we would do about it.
Discuss your programNot ready to book? Read the questions we hear most often or reach out by email.