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Transform preclinical development with predictive insights

Preclinical

Navigate preclinical development with greater confidence

Successfully navigating preclinical development requires expertise and biosimulation to ensure IND success. Certara enables scientists to predict human PK, optimize ADME, simulate drug interactions, and minimize animal studies.

We improve your success by proactively addressing CMC to avoid toxicity issues, planning your nonclinical studies, simulating ADME, predicting human PK from in vitro and animal studies, and assessing drug interactions, amongst many other preclinical tasks. For example, we predicted a First-In-Human dose 50-100X higher than traditional methods, reducing time on subtherapeutic doses and expediting development. Biosimulation can support your intellectual property by showcasing the distinctiveness of the drug’s mechanism of action.

How Certara enhances your preclinical phase

Predictive biosimulation

Anticipate challenges and address them early with comprehensive biosimulation tools and integrated data solutions.

Optimize nonclinical programs & safety assessments

Ensure high-quality drug substance and formulation to support robust safety evaluations and clinical attribute assessments.

Preparedness for regulatory compliance

Certara’s team, including former regulatory professionals, have extensive expertise in preparing for IND and CTA submissions.

Prepared for commercial and regulatory success

Certara bridges the gap between preclinical development and successful IND and CTA submissions with a unique combination of scientific expertise and technology platforms. Throughout the many challenges you face in preclinical development, you gain a competitive edge while staying compliant with regulatory standards.

  • Minimize risk with predictive biosimulation for FIH studies.
  • Reduce candidate attrition by evaluating toxicity and off-target effects early.
  • Gain regulator-ready insights that boost approval confidence.

Improve trial probability of success

Preclinical biosimulation improves clinical trials by predicting drug performance, dosing, adverse effects, and drug interactions. Certara’s predictive tools and decades of experience enable data-driven decisions for First-In-Human dosing, DMPK in target populations, and IND support, towards your trial’s success.

120
novel drugs approved by regulators used the Simcyp™ Simulator in lieu of clinical studies
90
Certara customers have received 90% or more of all novel drug approvals by the FDA from 2014-2024
21
regulatory agencies license Certara software products
700
drug development scientists and experts to advance your program leveraging tech-enabled decision-making

I’m thrilled to recommend Certara for FIH consulting projects. The PBPK consulting team delivered top-quality outputs, and their turnaround time was exceptional, and I especially appreciate the extra effort they put in to accommodating our tight deadlines. They went above and beyond to ensure our success.

Vassilios Aslanis
Vice President, Head of Clinical Pharmacology at Sudo Biosciences

We can help you find a solution

Contact us today to discuss how we can help you overcome your preclinical challenges.

De-risk your IND – Predict human PK, optimize ADME, and simulate drug interactions early to avoid costly setbacks.
Faster preclinical timeline – Reduce time spent on sub-therapeutic doses and streamline studies with biosimulation.
Regulatory confidence – Gain regulator-ready insights and predictive models to strengthen approval.
Fewer studies – Leverage data-driven decisions to improve accuracy, minimizing unnecessary experiments.

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