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...
Our innovative Cell and Gene Therapy services de-risk and accelerate drug development with our expertise from R&D to market access.
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...
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...
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...
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...
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...
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...
Explore the patient narrative format in medical writing and why narrative writing in clinical research is key to safety and accuracy.
We explore FDA requirements for providing nonclinical datasets in SEND format, including requirement dates by Study and Submission Types and FDA Center.
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