Company Description
Certara, Inc. (NASDAQ: CERT) is a software-focused company in the information sector that describes itself as a global leader in model‑informed drug development and biosimulation. According to the company’s public statements, Certara accelerates medicines using proprietary 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.
Certara’s core activities center on using computational modeling and simulation to help biopharmaceutical organizations design and evaluate therapies. The company states that it provides modeling and simulation, regulatory science, and assessment software and services that are intended to reduce the need for clinical trials, support regulatory submissions, and increase patient access to medicines. These offerings position Certara within the software publishers industry, with a focus on life sciences and healthcare applications.
Business focus and biosimulation platform
In its descriptions and news releases, Certara highlights biosimulation as the foundation of its business. Biosimulation combines software, data, and scientific expertise to model how drugs interact with biological systems and disease processes. Certara reports that its biosimulation software and services portfolio underpins both its software revenue and its services revenue, and that demand for model‑informed drug development solutions is a key driver of its commercial activity.
The company notes that it operates a mix of software products and scientific services. Software revenue is associated with its biosimulation and related platforms, while services revenue is linked to biosimulation services and regulatory‑related work. Certara’s public financial disclosures refer to growth in biosimulation software and services and to bookings that reflect customer demand for these offerings.
Key solution areas mentioned by Certara
Certara’s news releases describe several named software platforms and modules that illustrate its focus areas:
- Quantitative Systems Pharmacology (QSP): Certara IQ™ – The company has announced Certara IQ as a scalable, AI‑powered QSP solution. QSP is described as combining computational modeling and experimental data to examine how a drug interacts with biological systems and disease processes, helping scientists predict outcomes such as dosing, therapeutic window, and patient populations.
- Phoenix® Cloud and TFL Studio – Certara has introduced TFL Studio as the first cloud‑native module of its Phoenix Cloud solution. TFL Studio is described as enabling pharmacokinetic (PK) and pharmacodynamic (PD) scientists to create tables, figures, and listings (TFLs) for regulatory submissions and scientific publications, with a user‑friendly, no‑code environment and reusable templates.
- AI PK Reports and CoAuthor™ – The company has announced an AI PK Reports module that uses generative AI to turn tables, figures, and listings into draft PK reports. AI PK Reports are described as being powered by CoAuthor, Certara’s generative AI software for regulatory and medical writing.
- Integral™ data repository – Certara states that Phoenix Cloud integrates with Integral, its data repository that provides a single source of truth for PK/PD data, models, and visualizations.
- Pinnacle 21® Enterprise Plus – The company has launched Pinnacle 21 Enterprise Plus, which it describes as enabling clinical and statistical programmers to create, reuse, and manage data specifications for CDISC SDTM and ADaM datasets used in regulatory submissions. It is presented as a no‑code interface that supports industry and proprietary standards and integrates with downstream tools through application programming interfaces.
- Simcyp Simulator® – Certara references the Simcyp Simulator as a pharmacokinetic modeling and simulation tool used by regulatory agencies and biopharmaceutical companies. The company notes that it has been used in support of numerous regulatory drug approvals and is associated with a long‑standing consortium of biopharmaceutical members.
Scientific and regulatory orientation
Certara emphasizes the scientific credentials of its teams and the role of its software and services in regulatory contexts. The company reports that its scientists have authored hundreds of papers in pharmaceutical research and that multiple Certara scientists appear on external rankings of highly cited researchers. It also notes that its tools, such as the Simcyp Simulator and Pinnacle 21 solutions, are used by regulatory agencies and biopharmaceutical organizations in connection with regulatory submissions, clinical data standardization, and pharmacokinetic and pharmacodynamic analyses.
Through its modeling and simulation, regulatory science, and assessment offerings, Certara positions its technology as supporting decisions across the drug discovery and development process, from early research through clinical development and regulatory review. Its stated aim is to help clients reduce risk, shorten timelines, and transform how medicines reach patients.
Geographic presence and listing
Certara’s disclosures indicate that it has business presence in the Americas, which is identified as a key revenue‑generating market, as well as in the EMEA and Asia Pacific regions. The company’s common stock, with par value $0.01 per share, is listed on The Nasdaq Stock Market LLC under the trading symbol CERT. SEC filings show the company as being based in Radnor, Pennsylvania.
Capital structure and financing
According to its SEC filings, Certara and its subsidiaries are party to a credit agreement that provides term loans. An amendment to this credit agreement has modified the applicable interest rates on certain term loans, with the stated objective of reducing the company’s cost of borrowing and interest expense compared with prior terms. The company continues to report its financial results and outlook through periodic earnings releases and associated Form 8‑K filings.
Company status
Recent SEC filings and news releases show Certara continuing to trade on Nasdaq under the symbol CERT and to issue financial results, product announcements, and leadership updates. There is no indication in the provided materials of delisting, deregistration, bankruptcy, or a completed merger that would change its status as a standalone public company.
Frequently Asked Questions about Certara, Inc.
What does Certara, Inc. do?
Certara states that it accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. It provides modeling and simulation, regulatory science, and assessment software and services intended to help clients reduce clinical trials, support regulatory approval, and increase patient access to medicines.
In which industry and sector does Certara operate?
Certara is classified in the software publishers industry within the information sector. Its software and services are focused on applications for biopharmaceutical research, clinical development, and regulatory processes.
Where is Certara based and on which exchange is CERT stock listed?
SEC filings identify Certara, Inc. as being located in Radnor, Pennsylvania. Its common stock is registered on The Nasdaq Stock Market LLC under the trading symbol CERT.
What types of clients does Certara serve?
The company reports that its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. These organizations use Certara’s biosimulation software, technology, and services in drug discovery, development, and regulatory submissions.
What is model‑informed drug development?
In Certara’s description, model‑informed drug development involves using computational models and simulations to inform decisions throughout drug discovery and development. This includes biosimulation approaches such as quantitative systems pharmacology, pharmacokinetic and pharmacodynamic modeling, and other tools that help predict how drugs behave in biological systems.
What is Certara IQ?
Certara IQ is described by the company as a scalable, AI‑powered quantitative systems pharmacology (QSP) solution. It combines computational modeling and experimental data to examine how a drug interacts with biological systems and disease processes, supporting predictions around dosing, therapeutic window, and patient populations.
What is Phoenix Cloud and TFL Studio?
Phoenix Cloud is presented as a cloud‑based solution designed to accelerate pharmacokinetic workflows. TFL Studio, its first cloud‑native module, enables PK and PD scientists to create tables, figures, and listings for regulatory submissions and scientific publications in a no‑code, collaborative environment.
What is Pinnacle 21 Enterprise Plus?
Pinnacle 21 Enterprise Plus is a Certara solution for clinical and statistical programmers to create, reuse, and manage data specifications for CDISC SDTM and ADaM datasets. These datasets are required when sponsors present study safety and efficacy results and analyses to regulators, and the platform is described as supporting both industry and company‑specific standards.
How does Certara describe its scientific expertise?
Certara reports that its scientists have authored more than 200 papers in a recent year and that several of its researchers appear on external rankings of the top 2% most cited scientists globally. The company highlights this scientific output as evidence of its role in pharmacology, pharmacokinetics, and related disciplines.
How can investors track Certara’s performance?
Investors can review Certara’s periodic earnings press releases and associated Form 8‑K filings, which summarize financial results, bookings, and guidance. These documents are filed with the U.S. Securities and Exchange Commission and provide information on revenue, software and services performance, and other financial metrics.