Regulatory Operations Fact Sheet
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.
Arvinas Selects Certara’s D360 to Advance Speed and Efficiency of Discovery Research Case Study
Drug discovery scientists often waste time managing data instead of finding promising compounds. The right technology streamlines this process, leading to a more efficient DMTA (Design, Make, Test, Analyze) cycle. Without an integrated informatics platform, scientists face significant bottlenecks, hindering...
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...
Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19 Publication
As the global COVID-19 pandemic continues, unabated and clinical trials demonstrate limited effective pharmaceutical interventions, there is a pressing need to accelerate treatment evaluations. Among options for accelerated development is the evaluation of drug combinations in the absence of prior...
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...
Certara’s QSP Chronicles: World-renowned Thought Leadership Page
Explore Certara’s QSP Chronicles to learn about pioneering work in QSP, featuring influential research and thought leadership in drug development.
Secondary Intelligence Fact Sheet
Predicts off-target risks, streamlining secondary pharmacology analysis for safer drug development.
Payment Pressures in U.S. Specialty: Status quo and outlook for future financing On-Demand Webinar
To allow for the optimal positioning of your product, portfolio, or company, it is critical to understand the various forces that shape the US specialty access landscape. Certara’s teams have been tracking a wide range of critical market access developments...
