pre-update Archives

Press Coverage

Model-Informed Drug Development (MIDD) – EMA’s Advancement

Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from…

CertaraMarch 29, 2023

White Paper

Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling

Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic Drugs

CertaraMarch 22, 2023

On-Demand Webinar

Data-Backed Trial Design– Applying AI to Clinical Outcome Analysis

Global spending on clinical trials is expected to reach $68.9 billion per year by 2025…

CertaraMarch 17, 2023

Fact Sheet

eCTD Templates – A Springboard to Submission Success

CertaraMarch 17, 2023

Blog

Leveraging AI to Accelerate Drug Discovery: Vyasa Joins Certara

Applying Vyasa’s deep learning expertise to Certara products will enable our clients to expand how…

CertaraMarch 10, 2023

On-Demand Webinar

What you should know about FDA Project Optimus for your oncology drug approval

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…

CertaraMarch 10, 2023

On-Demand Webinar

RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes

Oops, I made a mistake! Everyone has made or seen one, and sometimes it is…

CertaraMarch 9, 2023

Press Release

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

Simcyp Simulator has been utilized to inform more than 300 label claims for 90+ novel…

CertaraMarch 7, 2023

Fact Sheet

GlobalSubmit™ eCTD Platform

GlobalSubmit enables teams to simplify the eCTD submission process to successfully publish, validate, and review…

CertaraMarch 3, 2023

Blog

Drug Development Considerations for Live Biotherapeutic Products

A new class of complex biologics has emerged in recent years. These are classified in…

CertaraMarch 3, 2023

pre-update

Model-Informed Drug Development (MIDD) – EMA’s Advancement

Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling

Data-Backed Trial Design– Applying AI to Clinical Outcome Analysis

eCTD Templates – A Springboard to Submission Success

Leveraging AI to Accelerate Drug Discovery: Vyasa Joins Certara

What you should know about FDA Project Optimus for your oncology drug approval

RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

GlobalSubmit™ eCTD Platform

Drug Development Considerations for Live Biotherapeutic Products

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