Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling

Rhea-AI Summary

Certara (NYSE:CERT) has achieved a significant regulatory milestone as its Simcyp® Simulator becomes the first and only software platform to receive European Medicines Agency (EMA) qualification for PBPK modeling in regulatory submissions across the EU.

The qualification, following a multi-year collaboration with EMA, enables pharmaceutical companies to use Simcyp Simulator for assessing drug-drug interaction (DDI) risk in regulatory submissions without re-establishing the platform's credibility. The qualification covers 3 context-of-use scenarios spanning 6 CYP enzymes and 2 inhibition mechanisms, potentially reducing the number of required clinical studies.

Positive

• First and only software platform to receive EMA qualification for PBPK modeling
• Streamlines drug submission process across EU by eliminating need to re-establish platform credibility
• Reduces required number of clinical drug-drug interaction studies for pharmaceutical companies
• Covers broad range of applications with 6 CYP enzymes and 2 inhibition mechanisms

Negative

• None.

RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA.

With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform’s credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. “This first of its kind qualification by EMA regulators of a new approach methodology further demonstrates the scientific value biosimulation provides to drug development scientists,” said William F Feehery, Chief Executive Officer. “This milestone reflects the value of Certara’s scientific leadership, innovation, and technical expertise.”

Drug-drug interaction (DDI) studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The qualification opinion covers various scenarios (3 COUs) where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform. The COUs span 6 CYP enzymes and 2 inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct.

“We’re at an inflection point in drug development as the industry and regulators increasingly prioritize model-informed drug development (MIDD). This recognition and regulatory trust from the EMA further solidify the future we’ve been working towards for numerous years,” said Rob Asbury, President, Certara Predictive Technologies. “This is yet another exciting stepping stone as we continue to empower drug developers to utilize mechanistic modeling to speed decision making, further scientific insights, and bring innovative medicines to patients faster.”

To learn more about the Simcyp Simulator and how it supports MIDD strategies, visit www.certara.com/simcyp.

About Certara

Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.

Certara contact:

Sheila Rocchio
Sheila.rocchio@certara.com

Media contact:

Alyssa Horowitz
certara@pancomm.com

FAQ

What is the significance of Certara's EMA qualification for the Simcyp Simulator?

The qualification makes Simcyp the first and only software platform approved for PBPK modeling in EU regulatory submissions, streamlining the drug development process by eliminating the need to re-validate the platform's credibility.

How will Certara's Simcyp EMA qualification impact drug development?

It will reduce the number of required clinical drug-drug interaction studies by allowing simulations to replace clinical studies across 3 context-of-use scenarios, covering 6 CYP enzymes and 2 inhibition mechanisms.

What types of drug interactions can be assessed with Certara's Simcyp Simulator?

The simulator can assess drug-drug interaction (DDI) risk using various scenarios where one drug acts as a substrate and another as a perpetrator, covering multiple CYP enzymes and inhibition mechanisms.

When did Certara receive the EMA qualification for Simcyp Simulator?

Certara received the EMA qualification for Simcyp Simulator in August 2025, following a multi-year collaborative engagement with the European Medicines Agency.