White Paper Archives

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

White Paper

Understanding Europe’s New Clinical Trial Regulations (EU-CTR)

While the new EU-CTR will help to streamline clinical trials, which will benefit both patients…

CertaraFebruary 27, 2023

White Paper

A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit

CertaraFebruary 8, 2023

White Paper

Certara’s combined PBPK/QSP model predicts safety and efficacy biomarker outcomes in Alzheimer’s Disease, as demonstrated in recent lecanemab work with Eisai

CertaraFebruary 2, 2023

White Paper

How Modeling & Simulation is Addressing the Immunogenicity Challenge: An academic nicety is now a drug development and regulatory differentiator

Learn how modeling and simulation can help drug developers overcome the immunogenicity challenge, a major…

CertaraJanuary 30, 2023

White Paper

How Drug Developers can Navigate the Inflation Reduction Act of 2022

Learn how the IRA will impact how new drugs are marketed and why negotiating pricing…

CertaraJanuary 27, 2023

White Paper

Drug interactions with therapeutic proteins, regulatory expectations and modeling and simulation approaches

CertaraJanuary 3, 2023

White Paper

The eCTD Submission Process: Tips and Tricks for Drug Development Success

Our experts compiled the tips and best practices you need to know for a successful…

CertaraNovember 22, 2022

White Paper

Driving Access to Rare Disease Treatments in Europe

CertaraJuly 11, 2022

White Paper

Axendia: Improving Healthcare Outcomes by Rewarding Value, NOT Cost

This research examines the use of value-based communications to support the transition to fee-for-outcomes models…

CertaraJune 28, 2022

White Paper

Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling

Understanding Europe’s New Clinical Trial Regulations (EU-CTR)

A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit

Certara’s combined PBPK/QSP model predicts safety and efficacy biomarker outcomes in Alzheimer’s Disease, as demonstrated in recent lecanemab work with Eisai

How Modeling & Simulation is Addressing the Immunogenicity Challenge: An academic nicety is now a drug development and regulatory differentiator

How Drug Developers can Navigate the Inflation Reduction Act of 2022

Drug interactions with therapeutic proteins, regulatory expectations and modeling and simulation approaches

The eCTD Submission Process: Tips and Tricks for Drug Development Success

Driving Access to Rare Disease Treatments in Europe

Axendia: Improving Healthcare Outcomes by Rewarding Value, NOT Cost

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