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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

Certara’s Virtual Twin® QSP Models: Transforming Rare Disease Research into Clinical Insights

Certara’s Virtual Twin® QSP Models are transforming rare disease drug development, with real-world insights from…

CertaraNovember 25, 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

Publication

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

The paper reviews current applications of pediatric PBPK across therapeutic areas and outlines where PBPK…

CertaraNovember 21, 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

Conference

2025 MFDS-KCDA Annual Conference

CertaraNovember 20, 2025

Conference

PHUSE APAC Connect 2026

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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

Quantitative Systems Pharmacology Modeling to Support the Preclinical Development of Radiopharmaceuticals

Quantitative Systems Pharmacology (QSP) modeling tackles preclinical radiopharmaceuticals development challenges, from design to dose optimization.

CertaraNovember 14, 2025

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

Certara’s Virtual Twin® QSP Models: Transforming Rare Disease Research into Clinical Insights

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

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

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

2025 MFDS-KCDA Annual Conference

PHUSE APAC Connect 2026

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

From Insight to Impact: Certainty EMEA 2025

Quantitative Systems Pharmacology Modeling to Support the Preclinical Development of Radiopharmaceuticals

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