Blog Archives

Blog

Navigating Market Access for Healthcare Products: The Power of the Global Value Dossier

This blog defines the global value dossiers and explains how BaseCase can support creating interactive…

CertaraJanuary 24, 2024

Blog

Understanding the Role of Your Discovery Asset’s Target Product Profile

If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly…

CertaraJanuary 19, 2024

Blog

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…

CertaraDecember 12, 2023

Blog

Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies

Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and…

CertaraNovember 17, 2023

Blog

The “Animal Rule” – What if a clinical trial simply isn’t ethical?

Clinical trials always pose a challenge to demonstrating a drug’s safety and efficacy. Sometimes, the…

CertaraNovember 10, 2023

Blog

How Biosimulation & AI Tech Could Solve Pharma’s R&D Productivity Crisis

Drug development continues to be painfully slow and mind-bogglingly expensive. In a 2010 article, Stephen…

CertaraOctober 27, 2023

Blog

Authoring & Assembling IND and CTA Applications – Insights and Updates

Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for…

CertaraOctober 23, 2023

Blog

Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling

This blog explains how Certara’s Simcyp team developed and tested a model in the Simcyp…

CertaraOctober 20, 2023

Blog

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

In this blog post, we explore the top 10 things you need to know about…

CertaraOctober 17, 2023

Blog

Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers?

Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV…

CertaraOctober 6, 2023

Blog

Navigating Market Access for Healthcare Products: The Power of the Global Value Dossier

Understanding the Role of Your Discovery Asset’s Target Product Profile

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies

The “Animal Rule” – What if a clinical trial simply isn’t ethical?

How Biosimulation & AI Tech Could Solve Pharma’s R&D Productivity Crisis

Authoring & Assembling IND and CTA Applications – Insights and Updates

Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers?

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