French SNDS Data Access and Analysis Page
Partner with Certara on RWE studies utilizing the French SNDS database, the most comprehensive resource in Europe covering 65+ million lives.
Complex Biologics Page
Certara’s Complex Biologics Services provide advanced support for CAR-T, monoclonal antibodies gene therapies. Trust our expertise to navigate regulatory pathways and enhance success.
Enabling Warp Speed Using the Hypervelocity Innovation Model: A Blue Print for Drug Development in Pandemics Publication
Pharmaceutical R&D is organized around prioritized investments, delivering on assets with the greatest return of investments. Linear sequencing of trials and financial risks are determinants of speed in an enterprise. There is less flexibility in leveraging expertise around priorities that...
Cell and Gene Therapy Page
Our innovative Cell and Gene Therapy services de-risk and accelerate drug development with our expertise from R&D to market access.
Intro to Smart In Silico Tools to Aid in Translating In Vitro & In Vivo Studies On-Demand Webinar
Safety issues account for about a quarter of the attrition in drug projects, and can arise from either the primary or secondary pharmacology. ToxStudio™ is an integrated modelling & simulation platform for safety pharmacology and toxicology, facilitating quantitative translation from...
Hyperlinking: Making the Most of Navigation in eCTD Submissions Blog Post
When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or...
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications Blog Post
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3 pertains to quality data. It has become increasingly common for sponsors to reference a Drug Master File (DMF) within this module. A DMF contains detailed information...
Submitting eCTD in Advance of a Milestone Application Blog Post
While advanced GPS systems and the advent of Big Data analytics are negating some of their advantages, early birds are still capturing worms at a good clip. We've heard this slogan since childhood. For those of you planning to implement...
The Role of a U.S. Agent Blog Post
Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go...
FDA’s New Module 1 is a Bridge to eCTD 4 Blog Post
Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a series on the Next Major Version (NMV) of eCTD, eCTD...
