Blog Archives

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

Developing Pediatric PBPK Models for Differing Ethnic Populations

Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because…

CertaraSeptember 29, 2023

Blog

Maximizing Reusability for Drug Submissions to Different Health Authorities

Many drug developers have products that they want to submit for marketing approval in several…

CertaraSeptember 21, 2023

Blog

Top Lessons Learned from 300 Regulatory Submissions

Who would have thought when we completed work on the first submission for which we…

CertaraSeptember 20, 2023

Blog

What is ICER & How Does it Impact the Pharmaceutical Industry?

The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization.…

CertaraSeptember 15, 2023

Blog

Methods to Increase Signal Finding in Rare Disease Drug Development

The regulatory landscape for drugs to treat rare diseases is being disrupted. Gleaning from several…

CertaraSeptember 8, 2023

Blog

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?

Developing Pediatric PBPK Models for Differing Ethnic Populations

Maximizing Reusability for Drug Submissions to Different Health Authorities

Top Lessons Learned from 300 Regulatory Submissions

What is ICER & How Does it Impact the Pharmaceutical Industry?

Methods to Increase Signal Finding in Rare Disease Drug Development

Newsletter sign up

Quick links

Solutions

Contact