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.
Discover Certara's regulatory submissions services for IND, NDA, BLA, and MAA. Ensure success with proven expertise, quality, and compliance for biopharma.
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...
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...
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...
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...
Explore Certara’s QSP Chronicles to learn about pioneering work in QSP, featuring influential research and thought leadership in drug development.
Predicts off-target risks, streamlining secondary pharmacology analysis for safer drug development.
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...
Partner with Certara on RWE studies utilizing the French SNDS database, the most comprehensive resource in Europe covering 65+ million lives.
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.