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Pre-clinical stage Solutions

Transition your research to clinical development seamlessly with our comprehensive pre-clinical development solutions

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regulatory nonclinical development plans VCLS

Depth and breadth of expertise

With deep expertise across regulatory, nonclinical, CMC, clinical research and market access, we deliver integrated solutions tailored to your product’s unique challenges, ensuring alignment with regulatory and market demands.

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Proven track record across all HealthTech products​

Whether you are developing small molecules or more complex biologics or medical devices, we are backed by a proven track record of guiding innovative therapies through preclinical milestones and into clinical success, we are your trusted partner in accelerating development and reducing risk.

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FAQs

How can we choose concentrations to be used in in vitro DDI studies?

It depends on product metabolism, the intended route of administration, and the type of DDI studies (inhibition vs. induction).

Can you help us generate nonclinical study reports, as we are lacking resources?

With pleasure! This activity is part of our DNA, and the complementary expertise of the nonclinical team allows drafting for any type of product and indication.

We consider that the toxicological evaluation of our drug could be done in one species only. Can you help us author a rationale justifying this approach?

Certainly. We would first need to evaluate your therapeutic target, type of product, targeted indication, and the regulatory environment.

Can you help us select a nonclinical CRO partner to support our nonclinical regulatory studies?

The choice of your nonclinical partner is critical to ensure that your product is evaluated appropriately. We can build with you a decision matrix to support an informed and rational choice.

We plan to reposition for a novel indication a well-known drug which was originally marketed in the 1960’s. Do we need to do any nonclinical work?

First, we would need to bring a sound pharmacological rationale for the new indication.

 

Then, we would have to consult the publicly available data and, depending on the quality of the data collected, decide if there is enough valuable information to predict the benefit/risk profile for humans. VCLS’ nonclinical team handles requests like these on a regular basis.

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Related Glossary

Pre-Clinical Data
Target Product Profile (TPP)
In Silico
Absorption, Distribution, Metabolism and Excretion (ADME) 
Ethics Committee (EC)
Overdose
Standard Exchange of Nonclinical Data (SEND)

Questions? Get the answers from our expert team ​

No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.​