eCTD Templates Page

Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.

Model-informed Vaccine Development Page

For the past four years, Certara has been developing a robust, regulatory-ready QSP platform for assessing and managing immunogenicity (IG).

Secondary Intelligence Page

Certara’s Secondary Intelligence | Predict and analyze off-target risks in drug development for safer outcomes.

Why Your Regulatory Writers Need eCTD Authoring Templates Blog Post

If you’ve heard about eCTD authoring template suites before, but you’re not sure what they do or whether they would be beneficial to your pharmaceutical company or CRO, you’ve come to the right place. Here I will explain what an...

PBPK modeling approaches to assess risks associated with bioequivalence in drug development On-Demand Webinar

In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting virtual bioequivalenceIVIVE-PBPK in biopharmaceuticsAn quantitative risk assessment approach for virtual bioequivalenceRole of inter-occasion variability and pharmacokinetic properties in virtual bioequivalence