Submission Leadership Page

Discover Certara's regulatory submissions services for IND, NDA, BLA, and MAA. Ensure success with proven expertise, quality, and compliance for biopharma.

Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Case Study

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. It is the only topical retinoid that selectively targets retinoic acid receptor gamma and is also the first new retinoid molecule...

Clinical trials of disease stages in COVID 19: complicated and often misinterpreted Publication

As of July 28, 2020, 1840 clinical trials were registered globally, with 1001 clinical trials recruiting patients for COVID-19 management.1 Despite this large number, only 30 trials have been published as peer-reviewed or preprint publications.2 Media reports and prepublications on medRxiv and bioRxiv represent the most...

Secondary Intelligence Fact Sheet

Predicts off-target risks, streamlining secondary pharmacology analysis for safer drug development.

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.