The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers Blog Post
By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy supply chains. To mitigate this risk, it is critical for biopharmaceutical manufacturers to properly maintain the documentation governing their continuity of operations. It’s complicated: Gene...
Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe Press Release
Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— March 2, 2021– Certara, Inc., a global leader in biosimulation, today announced the acquisition of AUTHOR!, a company that provides medical writing and statistical analysis of clinical trial...
Quantitative Systems Pharmacology for Drug Discovery and Development On-Demand Webinar
Certara's Dr. Piet van der Graaf, Senior Vice President, Professor of Systems Pharmacology, Leiden University, and Editor-in-Chief of Clinical Pharmacology and Therapeutics presents the opening lecture for Pharmacology 2020.
Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software Case Study
In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management software for their electronic common technical document (eCTD) submissions. The regulatory team at Prelude Therapeutics is very lean and responsible for more than 30 submissions...
Scientific Computing World: Connecting Science Press Coverage
Interconnection is an imperative for the modern laboratory, and seamless integration is mandatory from the perspective of the end user, who is generally a scientist. That’s the view of Leif Pedersen, president of software at Certara (...)
Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines Publication
Optimal use and distribution of coronavirus disease 2019 (COVID-19) vaccines involves adjustments of dosing. Due to the rapidly evolving pandemic, such adjustments often need to be introduced before full efficacy data are available. As demonstrated in other areas of drug...
Sealing Pharma Commercialization Deals: Creating Optimal Value for Investors On-Demand Webinar
It is crucial for biotech developers to engage in early commercial market assessment to generate value for Regulators, Payers, and Clinicians. This approach should be integrated with a clinical development strategy that will help drive acquisition potential, co-development prospects, and...
