Clinical Trials Archives

Fact Sheet

Expedited Pharmacometrics Regulatory Submissions

Certara delivers complete, compliant pharmacometric regulatory submission packages in just 4–6 weeks, eliminating the PMx…

Certara2025 年 12 月 8 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

Conference

2025 MFDS-KCDA Annual Conference

Certara2025 年 11 月 20 日

Conference

PHUSE APAC Connect 2026

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Certara2025 年 11 月 20 日

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 Pillsbury2025 年 11 月 12 日

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

Certara2025 年 11 月 5 日

On-Demand Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

Certara2025 年 11 月 3 日

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

Certara2025 年 10 月 31 日

On-Demand Webinar

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Learn how model-informed drug development, clinical pharmacology, and regulatory strategy support successful pediatric drug development…

Certara2025 年 10 月 21 日

Conference

Dutch Medicines Days

Certara2025 年 10 月 7 日

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临床试验

Expedited Pharmacometrics Regulatory Submissions

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

2025 MFDS-KCDA Annual Conference

PHUSE APAC Connect 2026

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Dutch Medicines Days

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