Built by a scientist
for the founders who
cannot afford to be wrong.
Kandih Bioscience exists because too many promising biotech programs are killed by the wrong studies — not by bad science, but by science misaligned with what the FDA actually requires. We close that gap, one program at a time.
A toxicologist who has
stood on both sides of
the FDA submission.
Dr. Harriet Kamendi is a board-certified toxicologist with [X+] years of experience in pharmaceutical safety assessment and regulatory strategy. She has supported [X+] IND submissions across small molecules, biologics, and combination products, and has guided emerging biotech teams through the regulatory pathways that determine whether a program lives or dies.
"Founders don't fail because the science is wrong. They fail because the science is misaligned with what FDA expects to see — and by the time they find out, it's already cost them a year."
Before founding Kandih, Harriet spent [X+] years at [previous firm or institution], where she designed GLP toxicology programs for [therapeutic area or company type]. Her published work spans [research areas], and she contributes to the regulatory toxicology community through [board memberships or affiliations].
She founded Kandih Bioscience to bring that depth of experience directly to the founders who need it most — the small biotech teams making high-stakes decisions without an internal regulatory function.
Great science deserves a
regulatory path that doesn't kill it.
Most biotech failures aren't scientific failures. They're strategic failures — the right molecule, the wrong study; the right indication, the wrong package; the right hypothesis, the wrong filing.
Kandih Bioscience exists to make sure brilliant biotech founders don't lose their programs to the regulatory system that was supposed to validate them. We help small teams make decisions with the same rigor that a top-tier in-house regulatory function would — without the cost of building one.
How we work
with founders, step by step.
Every engagement follows the same structure — whether it's a 90-minute strategy call or a multi-month program review. Clarity from day one, decisions you can act on every week.
Listen Before We Strategize
We begin with a structured intake to understand your molecule, your indication, your investors, and your timeline. Most consultants jump to recommendations. We don't — because the right strategy depends on which constraint matters most to you.
Map Against FDA Expectations
We assess your current data and plans against what FDA actually expects to see at your pathway and stage. This is where most companies discover gaps they didn't know existed — and where over-engineered studies become obvious.
Deliver Decisions, Not Documents
Every deliverable answers a specific question you can act on. "Do we need this study? Yes, with these parameters." No theoretical frameworks, no 80-page generic reports. Just the call, the reasoning, and the next step.
Stay With You Through Execution
Strategy without follow-through is just opinion. We stay engaged through CRO selection, protocol review, and FDA correspondence — making sure the plan we built actually gets executed the way it was designed.
We work best with
biotech founders
who move fast.
Kandih isn't built for everyone. We work best with a specific kind of company — and we're honest about who that is, because the wrong fit costs both of us time we don't have.
Early-stage biotech preparing for their first IND.
Typically seed through Series B, with a lead asset 12–18 months from IND filing. No internal regulatory function, or a single regulatory lead who needs a strategic sounding board. Decisions move quickly — the founder is in the room, and we work with them directly.
-
You're preparing for your first or second IND submission and need to get the tox strategy right the first time.
-
You have no internal regulatory toxicology function, or a small team that needs a senior strategic partner.
-
You want direct access to a senior toxicologist — not a layered consulting team with junior analysts doing the work.
-
You value fast, opinionated guidance over long generic reports. You want answers, not options.
-
You're moving toward FDA submission within 18 months and need a strategy that respects that timeline.
-
You need CRO-style execution services — we don't run wet-lab studies, we strategize and oversee them.
-
You have a large internal regulatory team and need supplementary capacity rather than strategic guidance.
-
You're focused on late-stage Phase 3 work or post-marketing — our edge is in early development.
-
You want comprehensive 80-page deliverables — we trade volume for clarity, and not every client values that.
-
You need cosmetic or OTC compliance only — while we offer this, our deepest expertise is biotech.
You've read the
approach. Now let's
talk about your program.
If anything you've read here sounds like the kind of partner you've been looking for, the next step is a conversation. No proposal, no scope of work — just 30 minutes to understand where you are and whether we're the right fit.
Book a 30-minute intro call.
Direct with Dr. Kamendi. No sales call. We'll understand your program, your stage, and whether Kandih is the right fit.
Schedule the Conversation Or send a message