Fact Sheet

文件质量和管理

Ensure submission readiness with Certara’s Document Quality services. We deliver compliant, inspection-ready regulatory documents that…

Certara2026 年 2 月 27 日

Fact Sheet

安全性与药物警戒撰写

Expertly delivering Safety & Pharmacovigilance Writing services, including Aggregate Safety Reports, Risk Management Plans, and…

Certara2026 年 2 月 27 日

博客

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…

Certara2026 年 2 月 26 日

Press Release

Certara Reports Fourth Quarter 2025 Financial Results; Provides Full Year 2026 Guidance

FY 2025 Revenue of $418.8M (9% growth) and Adj. EBITDA of $134.5M (10% growth) Fourth…

Certara2026 年 2 月 26 日

Guide

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

Certara2026 年 2 月 13 日

Guide

EMA Policy 0070 Submission Readiness Checklist

Use this EMA Policy 0070 Submission Checklist to prepare compliant clinical data packages, manage anonymization…

Certara2026 年 2 月 12 日

Blog

Pediatric drug development: From “wild west” to model-informed confidence

Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…

Certara2026 年 2 月 11 日

Publication

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…

Certara2026 年 2 月 2 日

Press Coverage

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…

Certara2026 年 1 月 30 日

Conference

AI in Drug Discovery 2026

Certara2026 年 1 月 30 日

Certara 服务