IND-Enabling & Preclinical
Nonclinical
Development
What you test before first-in-human echoes for a decade.
What you test before first-in-human echoes for a decade.
Nonclinical decisions made in IND-enabling studies echo through every later phase: a species that did not predict a signal, an exposure margin too thin to defend, a study designed to answer the wrong question. We help sponsors build a fit-for-purpose pharmacology, pharmacokinetics, and toxicology program, calibrated to your modality, route, and likely first-in-human design, so you neither under-test and face a hold nor burn capital on studies the agency never asked for.
Toxicology, PK, and safety pharmacology built to answer the questions still to come.
The whole preclinical program exists to answer one question with confidence: the dose at which a human is first exposed. Each discipline contributes a piece, and the number that results has to survive review.
Derived the way the agency expects: NOAEL to human equivalent dose with justified safety factors, or MABEL for higher-risk biologics, with a rationale that survives review.
Toxicology, DMPK, and safety pharmacology all resolve into the dose a human is first exposed to.
An IND lives or dies on a coherent nonclinical package. Each discipline answers a different question, and the exposure data ties them all together.
The studies the agency will actually want to see, sized to your modality and route.
The GLP battery, and the interpretation that turns raw findings into a defensible position on human safety. Reviewers do not expect a perfectly clean program; they expect you to know what each finding means.
The systems that fail fastest when a drug goes wrong: heart, brain, and lungs. The ICH S7A/S7B core battery, cardiac liability from hERG through in vivo QT, and off-target screening.
Exposure is the through-line. It converts an animal dose into a human projection, sets the safety margins, and explains why a species did or did not predict a signal — on ICH M10-validated methods a reviewer can trust across every lab that ran them.
A finding is not a failure until it is unexplained.
Toxicology programs rarely come back perfectly clean, and reviewers do not expect them to. What they expect is interpretation: whether a finding is adverse, whether it is monitorable in the clinic, and what it means for the safety margin. We build the toxicology narrative that turns findings into a position the agency can accept, so a signal becomes a managed risk rather than a clinical hold.
New modalities and outsourced studies both need a hand that has done it before.
Standard tox paradigms assume a small molecule. Biologics need a pharmacologically relevant species and an immunogenicity strategy; cell and gene therapies raise biodistribution, persistence, and tumorigenicity questions no repeat-dose study answers. We build the program these modalities actually require and align it with the division early.
A GLP study is only as good as its protocol and its oversight, and a CRO will run exactly what you signed, not what you meant. We choose the right lab, negotiate the protocol and price, monitor the in-life work, and challenge a draft report before it hardens into the version the agency sees.
A nonclinical program is judged on interpretation as much as data. Your leads are senior toxicologists, DMPK scientists, and nonclinical regulatory practitioners who have designed IND-enabling packages, justified first-in-human doses, and defended them through review across modalities.
We build the narrative that explains a finding, because an unexplained result is what turns into a clinical hold.
A package sized to your modality, route, and first-in-human design, not a gold-plated one the agency never asked for.
Small molecule, biologic, and the cell and gene therapies where the standard paradigm no longer applies.
We manage the labs that run your studies, catching the deviations and challenging the reports before the agency does.
A nonclinical package opens the IND and feeds everything after it. These are the services it connects to most.
The strategy and the pre-IND meeting that decide what the nonclinical package actually has to prove.
Explore FDA →The manufacturing and material that the toxicology studies are run on, kept consistent with the clinical product.
Explore CMC →Where an expedited program compresses the nonclinical timeline, and the data has to mature faster than usual.
Explore Pathways →Tell us where your program stands: lead candidate, IND-enabling, or mid-study with a finding to interpret. We'll match you with a senior nonclinical lead and respond within one business day. All inquiries are strictly confidential.
