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Press Coverage

Dose Optimization: Getting it Right for Vulnerable Populations

By: Justin Hay & Frank Engler Pandemics amplify existing strengths and vulnerabilities—not only highlighting who…

CertaraMay 22, 2023

Blog

Japan’s Approach to Pediatric Drug Development: What You Need to Know

Access to safe and effective medications is critical for pediatric patients, yet 60-70% of medicines…

CertaraMay 22, 2023

Announcement

Certara’s Synchrogenix Writer now enhanced with AI Layar

Next generation automation for Medical Writers to streamline the creation of regulatory documents Certara is…

CertaraMay 11, 2023

Case Study

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

RedHill Biopharma Ltd., a specialty biopharmaceutical company, developed RHB-204, a treatment for MAC, and needed…

CertaraMay 9, 2023

Press Coverage

The Impact of the Inflation Reduction Act on Biosimilar Uptake

In an interview with HCPLive, Maximilian Vargas, PhD, MBA, vice president of the United States…

CertaraMay 8, 2023

Blog

What is a Global Risk Mitigation Plan & how can you use it to ensure a successful drug launch?

A Global Risk Mitigation Plan (GRMP) is a critical step in drug development as it…

CertaraMay 4, 2023

Press Coverage

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

2023 guidance from FDA on dosages in oncology provides further context on expectations with Project…

CertaraMay 3, 2023

Blog

SEND Dataset Quality Control: Best Practices & Recommendations

In this blog, Senior Product Management Director Peggy Zorn explores best practices & recommendations for…

CertaraApril 25, 2023

On-Demand Webinar

How digital communication tools will revolutionize your medical conversation

Medical Affair, Market Access, and Sales & Marketing teams at most of pharmaceutical companies use…

CertaraApril 24, 2023

Press Coverage

Overcoming CMC challenges in cell and gene therapy: part II

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven…

CertaraApril 22, 2023

Dose Optimization: Getting it Right for Vulnerable Populations

Japan’s Approach to Pediatric Drug Development: What You Need to Know

Certara’s Synchrogenix Writer now enhanced with AI Layar

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

The Impact of the Inflation Reduction Act on Biosimilar Uptake

What is a Global Risk Mitigation Plan & how can you use it to ensure a successful drug launch?

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

SEND Dataset Quality Control: Best Practices & Recommendations

How digital communication tools will revolutionize your medical conversation

Overcoming CMC challenges in cell and gene therapy: part II

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