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Regulatory Operations Best Practices for Health Canada Submissions

Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…

CertaraAugust 11, 2025

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Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development

Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…

CertaraAugust 6, 2025

Blog

Breaking New Ground: EMA Qualification of the Simcyp® Simulator Ushers in a New Era for PBPK Modeling

The Simcyp Simulator receives EMA qualification—the first and only PBPK platform formally qualified for any…

CertaraAugust 5, 2025

Blog

Machine Learning (ML) in healthcare

Learn about 3 distinct examples of machine learning (ML) in healthcare that utilize different techniques…

CertaraAugust 1, 2025

Blog

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

GSK shares real-world case studies on how Model-Based Meta-Analysis (MBMA) supports dose selection, virtual control…

CertaraJuly 31, 2025

Blog

Recapping a record-breaking 2025 Krakow HTA Symposium

We cover the key takeaways from CERTAINTY 2025, including the power of Model-Informed Drug Development…

Simona ColucciJuly 30, 2025

Blog

How Pharma Can Transition to Non-animal Studies for Investigational Drugs

Pharma companies can ease the transition to non-animal studies for investigational drugs by leveraging NAMs…

CertaraJuly 25, 2025

Blog

ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered

ADNCA is transforming non-compartmental analysis by standardizing workflows, enhancing regulatory confidence, and enabling scalable automation.…

CertaraJuly 23, 2025

Blog

MIDD can ease pediatric & rare disease drug loss in Japan

Certara tackles pediatric cancer and rare disease drug loss in Japan by advocating MIDD, which…

CertaraJuly 8, 2025

Blog

The Reference-scaled Average Bioequivalence (RSABE) Approach

We examine the Reference-scaled Average Bioequivalence (RSABE) approach for generic drug development and how it…

CertaraJuly 1, 2025

Blog

Regulatory Operations Best Practices for Health Canada Submissions

Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development

Breaking New Ground: EMA Qualification of the Simcyp® Simulator Ushers in a New Era for PBPK Modeling

Machine Learning (ML) in healthcare

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

Recapping a record-breaking 2025 Krakow HTA Symposium

How Pharma Can Transition to Non-animal Studies for Investigational Drugs

ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered

MIDD can ease pediatric & rare disease drug loss in Japan

The Reference-scaled Average Bioequivalence (RSABE) Approach

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