
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.
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.
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…
In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit,…
Discover essential tips for formatting annotated CRFs, from dual bookmarking to document properties. Read the 2nd blog post in this series.
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…
Certara’s Regulatory Submissions Services: Expert guidance for IND, NDA, BLA, and MAA submissions, ensuring quality, efficiency, and compliance for biopharmaceutical companies.
Our medical affairs consulting services ensure compliance, streamline timelines, and reduce internal burdens.