Pharma positions itself for 2026 amid an evolving US landscape Press Coverage Pharma positions itself for 2026 amid an evolving US landscape Explore how U.S. policy changes — including tariffs, onshoring, and Most Favored Nation pricing —…CertaraDecember 22, 2025
A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection Publication A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection This study synthesizes data from a large body of clinical trials to evaluate rates of…CertaraDecember 18, 2025
Accelerated ADC Approval Through Expert Modeling and Data Rescue Case Study Accelerated ADC Approval Through Expert Modeling and Data Rescue See how Certara rescued complex ADC PK datasets, delivered PopPK, exposure-response modeling, and enabled rapid…CertaraDecember 15, 2025
Merck Advances Pediatric Oncology with Innovative ADC Modeling Case Study Merck Advances Pediatric Oncology with Innovative ADC Modeling Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…CertaraDecember 12, 2025
New Approach Methodologies (NAMs): By the numbers Guide New Approach Methodologies (NAMs): By the numbers We outline today’s animal-use landscape, the rise of NAMs, & how the Non-Animal Navigator supports…CertaraDecember 10, 2025
Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings Announcement Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.CertaraDecember 3, 2025
10 Strategic Foundations for Early Drug Development Guide 10 Strategic Foundations for Early Drug Development Discover effective Early Drug Development strategies to navigate early development with confidence and clarity. Download…CertaraNovember 26, 2025
The Stepwise PIP is Here to Stay: From Pilot Flexibility to Permanent EU Regulation Blog The Stepwise PIP is Here to Stay: From Pilot Flexibility to Permanent EU Regulation The stepwise Paediatric Investigation Plan (PIP) is a strategic, flexible route for drug developers navigating…CertaraNovember 26, 2025
The Proposed Food and Drug Administration (FDA) Development Safety Update Report (DSUR) Guidance Blog The Proposed Food and Drug Administration (FDA) Development Safety Update Report (DSUR) Guidance Learn how FDA DSUR requirements reshape drug safety reporting, align with ICH E2F, and impact…CertaraNovember 24, 2025