Certara Services Archives

Press Coverage

The one-trial era: what the FDA’s shift signals for the future of drug development

The FDA is shifting toward approving drugs based on a single pivotal trial supported by…

CertaraMay 6, 2026

Blog

Optimize Readiness for MHRA-NICE Aligned Pathway

Achieve HTA and regulatory success in the MHRA–NICE pathway through early evidence alignment.

CertaraMay 1, 2026

Blog Knowledge Base

Understanding LC/MS/MS

Discover LC/MS/MS applications in therapy development and bioanalytical method development for robust, compliant pharmaceutical research.

CertaraMay 1, 2026

Video

Certara Talks – Pivotal Trial Mandate

Explore how the FDA’s shift toward one pivotal trial plus supporting evidence could reshape drug…

CertaraApril 22, 2026

On-Demand Webinar

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…

CertaraApril 10, 2026

Conference

AMWA NorCal Pacific Coast Conference

Danielle PillsburyApril 8, 2026

Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

CertaraApril 7, 2026

On-Demand Webinar

Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD

Discover practical strategies to increase regulatory trust and acceptance of MIDD models, including PBPK and…

CertaraApril 6, 2026

On-Demand Webinar

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Watch this on-demand webinar to learn how the final ICH M15 guidance is shaping Model-Informed…

CertaraApril 2, 2026

Publication

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…

Danielle PillsburyApril 2, 2026

Certara Services

The one-trial era: what the FDA’s shift signals for the future of drug development

Optimize Readiness for MHRA-NICE Aligned Pathway

Understanding LC/MS/MS

Certara Talks – Pivotal Trial Mandate

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

AMWA NorCal Pacific Coast Conference

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

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