Certara Services Archives

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

Publication

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Immunogenicity poses a significant challenge in biotherapeutics development due to the formation of anti-drug antibodies…

Danielle PillsburyNovember 7, 2025

Fact Sheet

Build investor confidence with science-backed strategy

Discover expert insights on biotech funding, startup investment strategies, and securing capital for biotech ventures.…

CertaraNovember 6, 2025

Press Release

Certara Reports Third Quarter 2025 Financial Results

RADNOR, PA— November 6, 2025-- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development,…

CertaraNovember 6, 2025

Webinar

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

CertaraNovember 6, 2025

White Paper

Web of Evidence: A Practical Guide to Managing Document Dependencies in eCTD Submissions

Discover a practical framework to plan, author, and manage regulatory submissions using document dependency mapping.

CertaraNovember 6, 2025

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

CertaraNovember 5, 2025

Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Danielle PillsburyNovember 3, 2025

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

CertaraOctober 31, 2025

Certara Services

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Build investor confidence with science-backed strategy

Certara Reports Third Quarter 2025 Financial Results

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Web of Evidence: A Practical Guide to Managing Document Dependencies in eCTD Submissions

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

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