This segment focuses on providing software products and technology-enabled services for model-informed drug development. It encompasses a range of solutions, including mechanistic and empirical biosimulation platforms, data standardization tools, and regulatory submission support. Research and development activities include continuous improvement of existing software and the development of new tools to address emerging challenges in drug development. Technologies and methodologies employed include pharmacokinetic/pharmacodynamic (PK/PD) modeling, population PK, and physiologically based pharmacokinetic (PBPK) modeling. This segment supports various therapeutic areas, including oncology, cardiology, and immunology, by enabling more efficient and effective drug development processes. The patient impact is significant, as these tools help accelerate the development of safe and effective medicines. Certara's market positioning is strong, with a focus on providing innovative solutions to biopharmaceutical companies. Future opportunities include expanding into new therapeutic areas and enhancing the capabilities of existing software platforms. Regulatory and clinical aspects are central to this segment, as the software and services are used to support regulatory submissions and clinical trial design. Partnerships and collaborations with biopharmaceutical companies and regulatory agencies are crucial for success.

This segment offers technology-driven services to guide customers' new drugs through the regulatory submission process and into the market. It includes services such as drug development and regulatory strategy, clinical pharmacology, model-based meta-analysis, regulatory writing and medical communications, and market access support. Research and development activities focus on improving the efficiency and effectiveness of drug development processes, including clinical trial design and data analysis. Technologies and methodologies used include advanced statistical modeling, data analytics, and regulatory expertise. This segment supports a wide range of therapeutic areas, including oncology, cardiovascular diseases, and infectious diseases. The patient impact is significant, as these services help accelerate the development and approval of new medicines. Certara's market positioning is strong, with a focus on providing comprehensive solutions to biopharmaceutical companies. Future opportunities include expanding into new therapeutic areas and enhancing the capabilities of existing services. Regulatory and clinical aspects are central to this segment, as the services are directly related to regulatory submissions and clinical trial design. Partnerships and collaborations with biopharmaceutical companies and regulatory agencies are crucial for success.