Certara Services Archives

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…

Certara2025 年 12 月 12 日

Conference

ICoP 2026 India

Danielle Pillsbury2025 年 12 月 11 日

Guide Infographic

New Approach Methodologies (NAMs): By the numbers

We outline today’s animal-use landscape, the rise of NAMs, & how the Non-Animal Navigator supports…

Certara2025 年 12 月 10 日

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.

Certara2025 年 12 月 3 日

Guide

10 Strategic Foundations for Early Drug Development

Discover effective Early Drug Development strategies to navigate early development with confidence and clarity. Download…

Certara2025 年 11 月 26 日

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…

Certara2025 年 11 月 26 日

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…

Certara2025 年 11 月 24 日

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…

Certara2025 年 11 月 20 日

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™…

Certara2025 年 11 月 17 日

Blog

From Insight to Impact: Certainty EMEA 2025

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

Certara2025 年 11 月 17 日

Certara 服务

Merck Advances Pediatric Oncology with Innovative ADC Modeling

ICoP 2026 India

New Approach Methodologies (NAMs): By the numbers

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

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

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