Certara Services Archives

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

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

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

Poster

Early Systematic PICO Scenario Identification and Prioritization for EU HTA Joint Clinical Assessments

Discover a systematic, AI-enabled approach to early PICO scenario identification and prioritization to improve EU…

CertaraNovember 20, 2025

Guide

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

The FDA is phasing out animal testing of new drugs. Learn how Certara’s Non-Animal Navigator™…

CertaraNovember 17, 2025

Blog

From Insight to Impact: Certainty EMEA 2025

See how GenAI, unified digital trials, and a Totality of Evidence approach transform regulatory docs,…

CertaraNovember 17, 2025

Blog

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

At ACoP 2025, Certara showcased innovation with the launch of Certara IQ™ and Phoenix® Cloud,…

CertaraNovember 13, 2025

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

CertaraNovember 12, 2025

Announcement

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Certara’s new survey findings show that 50% of Americans are unaware of FDA and NIH…

CertaraNovember 12, 2025

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

Certara Services

10 Strategic Foundations for Early Drug Development

The Stepwise PIP is Here to Stay: From Pilot Flexibility to Permanent EU Regulation

The Proposed Food and Drug Administration (FDA) Development Safety Update Report (DSUR) Guidance

Early Systematic PICO Scenario Identification and Prioritization for EU HTA Joint Clinical Assessments

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

From Insight to Impact: Certainty EMEA 2025

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

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