Safety is Infrastructure.

At Kandih BioScience, we design the FDA evidence that protects capital — the nonclinical strategy, biological evaluation, and safety substantiation that determine whether an asset clears, holds, or trades at the value its founders modeled.

We work with founders, early product teams, and the investors backing them, across FDA-regulated products: drugs, biologics, medical devices, diagnostics, combination products, cosmetics under MoCRA, dietary supplements, and medical foods.

The work shows up as:
— Nonclinical & toxicology strategy. IND-enabling packages aligned to ICH M3(R2), GLP study design, CRO oversight, WoE analyses.
— Biological evaluation. ISO 10993-1 plans, chemical characterization (10993-18), toxicological risk assessment under 10993-17:2023 — built to survive submission, diligence, and inspection under the new QMSR.
— Submission strategy. IND, NDA, 510(k), De Novo, CE-Mark, pre-sub and Q-Sub planning that anticipates the reviewer's questions before they're asked.
— Safety substantiation. MoCRA files, NDI notifications, claim substantiation, and ingredient dossiers built to withstand FDA, retailers, and plaintiffs.

A clearance is a snapshot. The governance is what gets purchased.

Most of what becomes a clinical hold, a diligence discount, or a 483 observation was — years earlier, in the first room — a question of which study to design, which exposure to evaluate, and which authority to put in the room. That's the work we do.

Talk to us if you are a founder scoping a first IND, 510(k), or pre-sub; an investor diligencing a regulatory plan before writing a check; or a team that needs a submission partner who reads the package the way the agency, the acquirer, and the inspector will.

— Harriet Kamendi, PhD, DABT
Founder & CEO, Kandih BioScience
hkamendi@kandih.com

#SafetyIsInfrastructure #RegulatoryToxicology #FDA #MedicalDevices #Biologics #MoCRA #NonclinicalStrategy

Kandih Bioscience

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Kandih Bioscience

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