Broadens European footprint with integrated regulatory services and statistical analysis
PRINCETON, NJ.— 三月 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 data to global pharmaceutical and biotechnology companies. Founded in 1998, AUTHOR! is based near Amsterdam in the Netherlands.
AUTHOR! has regulatory and biostatistical expertise in a wide range of therapeutic areas, including oncology, cardiovascular diseases, and rare diseases. Additionally, the company has extensive experience analyzing clinical trial data and preparing regulatory submissions to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), which completed its relocation to Amsterdam from London last year.
“We are excited to welcome AUTHOR! to Certara,” said Demetrius Carter, senior vice president of Certara’s Synchrogenix division. “This acquisition adds to our existing regulatory and biostatistical expertise and helps to fuel our strategic expansion in Europe. The addition of AUTHOR!’s seasoned team allows us to leverage our technology-enabled capabilities and further help our global clients expertly navigate and accelerate the drug development and regulatory approval process.”
Biopharmaceutical R&D spend exceeds $30 billion annually in Europe, with Certara currently partnering with the top ten European-based biopharmaceutical companies by R&D spend. In 2020, Certara’s customers received the majority of novel drugs and biologics approved by the EMA.
“We are very pleased to be joining the Certara family,” said Annemieke van Hest, founder of AUTHOR! “I am confident in the world-class support that we can deliver together by mining insights from clinical trial data and expediting regulatory approvals.”
Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.
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Elizabeth Tang, Ph.D.