Non-clinical development

Non-clinical development

Non-clinical development

Before any human trial, the quality of your non-clinical data determines whether you can move forward with confidence. KLIFO’s senior consultants help design and manage studies that regulators can trust and developers can build on. That’s how we strengthen the foundation of non-clinical development.

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Non-clinical development: generating the data that drives approvals

Drug development doesn’t begin in the clinic — it begins with the data that supports clinical development. This data is generated through laboratory and animal studies that assess how a drug behaves before it is ever tested in humans. At KLIFO, our non-clinical development services provide the hands-on execution, strategic insight and regulatory alignment needed to generate the right data, in the right way, at the right time.
We help biotech and pharmaceutical companies bridge the gap between potential and approval — so that promising candidates can reach the patients who need them.

A preclinical CRO with a non-clinical mindset

While the terms are often used interchangeably, there is a subtle but important difference: non-clinical development covers all safety and efficacy studies not involving humans, including those that support early research, regulatory filings, and lifecycle management. Preclinical development refers more narrowly to the studies required before first-in-human trials.

At KLIFO, we combine the breadth of non-clinical understanding with the focus of a preclinical CRO—offering tailored support for the entire IND-enabling process and beyond.

About KLIFO

Services designed for approval—not just compliance

Our clients don’t come to us for standard packages. They come to us because they need clarity, strategic sparring, and executional excellence—often under significant time and cost pressure.

We act as non-clinical project leads, advisors, and regulatory co-pilots. Whether the challenge is CRO selection, study design, dose translation or gap analysis, we work as part of your internal team to get it done.

All delivered with the level of proactivity, regulatory maturity, flexibility, and seniority that KLIFO is known for.

Our services include:

Non-clinical development strategy and planning

IND/CTA-enabling study design

Toxicology (acute, sub-chronic, chronic)

Pharmacology (in vitro and in vivo efficacy, MoA, PK/PD, ADME, DMPK)

Dose translation and MTD assessments

Regulatory documentation (IB, non-clinical sections for IND/IMPD/BLA/NDA/MAA)

GLP and non-GLP study coordination

Gap analyses and due diligence evaluations

CRO identification, contracting and management

Support across drug and drug-device combinations

Target Product Profile (TPP) development aligned with overall drug development strategy

Guidance through every phase

Wherever you are in development, KLIFO makes sure each step connects.
The metro map shows how non-clinical development links into the bigger journey

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Real-world impact:

From gap to approval

A biotech company developing a novel small molecule for a neurological disease contacted KLIFO after realizing the complexity of translating their early-stage efficacy signals into a regulatory-compliant preclinical package. Our team supported them with a non-clinical gap analysis, strategic study planning, and CRO management — ensuring generation of the relevant and adequate data supporting further development.

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Real-world impact:

Fast-track toxicology to avoid delays

In another case, a mid-sized pharmaceutical company required a fast-track toxicological evaluation of leachables from new packaging materials for a marketed product. KLIFO delivered the required documentation within a short timeline, helping them avoid delays in their regulatory resubmission.

These are just two examples of how we work— closely embedded with our clients, from design to delivery.

The KLIFO difference: Partnership, not packages

KLIFO is not a traditional CRO. We’re a consultancy partner that brings operational expertise and strategic depth into your development program. Our team includes highly experienced non-clinical specialists who stay with your project — not just until the contract is signed, but until the data is delivered and the next step is secured.

In fact, many of our consultants are involved before contracts are even finalized — joining early discussions to shape the right approach from the start. And when you work with one of us, you gain access to the insights of our entire l team — through active sparring and shared experience across disciplines.

We don’t just design studies. We help define what matters — and we execute on it.

True partnership with flexible, tailored solutions

Faster turnaround and reduced time-to-clinic

Confidence in regulatory submissions

Integrated support from strategy to execution

Direct access to the experts doing the work

Quick response times and proactive project execution

Ready for your next milestone?

Whether you’re transitioning from candidate selection to your first in man study or need toxicological evaluation for a marketed asset, KLIFO can step in where you need us most.

Reach out to learn how our non-clinical development services can help de-risk your program, accelerate timelines, and build a stronger foundation for approval.

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