Don't let the FDA stop your
program.
IND.
Section 505.
launch.
We prevent it.
Kandih Bioscience helps biotech startups and cosmetic firms navigate FDA expectations before they spend millions on the wrong studies. Expert guidance from Harriet Kamendi, PhD, DABT.
Clinical Hold – Pre-IND Package Deficiencies
Incomplete or misaligned tox data forces FDA to hold your IND. Avg. delay: 6–18 months.
Over-Designed GLP Studies
Running full GLP tox when bridging data would have sufficed. Cost impact: $500K–$2M+.
Kandih Pre-IND Strategy Session
Align your tox package with FDA's actual expectations before a single study is run.
Every wrong study is a
costly delay you
cannot afford.
FDA doesn't just reject bad science — it rejects misaligned science. The cost of a clinical hold or an over-engineered study isn't just money. It's momentum, investor confidence, and time to market.
Kandih Bioscience exists to close the gap between what founders think FDA needs and what FDA actually requires.
We don't offer
generic consulting.
We solve specific
regulatory problems.
Each service is built around the questions companies ask when they are under real pressure — before the IND, before the study, before the hold.
View all servicesPre-IND Toxicology Roadmap
Understand exactly what tox data FDA will expect to see in your IND package — before you commission a single study. Avoid clinical holds on Day 1.
Download Checklist505(b)(2) Strategy: Minimize Your Tox Burden
For reformulations, new dosage forms, and drug repurposing. We map existing tox data to your program and identify exactly where gaps exist — and where they don't.
Schedule a Strategy CallBiocompatibility for Medical Devices
New ISO 10993 and FDA expectations are stricter than ever. We review your testing plan against current guidance and identify gaps before your IDE submission.
Book Gap ReviewCosmetic & OTC Compliance
MoCRA introduced facility registration, product listing, and adverse event reporting requirements. We help cosmetic brands understand exactly what applies to them.
Request AssessmentGLP Study Design & Vendor Oversight
Design studies that generate defensible data the first time. We review protocols, select appropriate models, and oversee CRO execution to FDA standards.
Talk to an ExpertRegulatory Writing & FDA Meeting Support
Pre-IND meeting packages, Type B meeting requests, and briefing documents written by a scientist who understands both the science and the regulatory strategy.
Request Scope Review
Do you need
GLP tox studies
yet?
Use this framework to understand where your program stands. Most founders are surprised by the answer — often they are either moving too fast or waiting too long.
Are you planning to file an IND or IDE within the next 12–18 months?
GLP studies are almost certainly needed. The question is which ones, at what dose, and in what species. This is where pre-IND strategy matters most.
You likely don't need GLP yet. Non-GLP mechanistic and range-finding studies are appropriate. Running GLP now is probably premature.
Is your molecule a New Molecular Entity, or does existing tox data exist for your compound?
Full GLP tox package required: 2-species repeat-dose, genotox battery, safety pharmacology. Timeline planning is critical.
Bridging strategy may apply. Significant tox cost reduction is possible. You need an expert to map existing data gaps.
Generic checklists won't protect you. The right answer depends on your molecule, your indication, and FDA's current thinking on your pathway. A 60-minute strategy call with Kandih can save you months and millions.
Take the full diagnostic
Not sure where
your program falls?
Get a personalized GLP readiness assessment from Dr. Kamendi.
Start with the
right conversation,
not a proposal.
Three entry points designed for founders and regulatory leads at different stages of urgency.
Regulatory Readiness Assessment
A structured review of where your program stands against FDA's expected tox requirements. Delivered as a written summary with clear next steps.
Regulatory Roadmap Session
A 90-minute deep-dive into your specific molecule, indication, and pathway. We map the tox studies required and flag the highest-risk gaps.
Gap Review (Testing Plan or Protocol)
Submit an existing testing plan, protocol, or biocompatibility matrix for expert review against current FDA and ISO expectations.
Tell us about
your program.
We respond to all qualified inquiries within 1 business day.
Scientific depth.
Regulatory fluency.
Kandih Bioscience is a boutique regulatory toxicology consultancy. We exist because most startups don't have the internal expertise to navigate FDA's evolving expectations — and the cost of that gap is enormous.
PhD in Toxicology + DABT Certification
Harriet Kamendi is a Diplomate of the American Board of Toxicology — the highest credential in the field.
IND, IDE, and NDA Experience
Hands-on experience across multiple regulatory pathways including both small molecules and biologics.
GLP Study Design & CRO Management
Protocol design, vendor selection, and monitoring — ensuring studies are defensible on the first attempt.
Cosmetic & Personal Care Expertise
Navigating MoCRA, EWG standards, and global regulatory requirements for beauty and wellness brands.
Harriet Kamendi, PhD, DABT
Principal Scientist & Founder, Kandih Bioscience Kandih Group LLC · Gaithersburg, MD
A 60-minute call can save
your program months.
Don't commission another study until you know it's the right one. Let's review your program together.