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Company News Release
Purchase adds global regulatory writing and submissionservices to Certara?s drug development consulting expertise
Certara, the leading technology-enabled drug development and drug safety consultancy, announced today that it has acquired specialty contract research organization (CRO) Synchrogenix Information Strategies Inc. Synchrogenix offers regulatory writing and related services to pharmaceutical, biotechnology and medical device companies worldwide.
Dr. Donald A. Deieso, Chairman of Certara, said, “Pharmaceutical companies are looking for greater value and increased synergies from their outsourcing partners. Adding the complementary services Synchrogenix offers to the Certara portfolio will allow Certara to provide its preclinical and clinical pharmacology customers with end-to-end drug development consulting and writing services, including preparation of regulatory submissions such as the Biologic License Application, Investigational New Drug and New Drug Applications.”
“We were attracted to Synchrogenix by the quality of its work, its outstanding reputation and the global network of regulatory experts that it has developed. By combining the most sophisticated regulatory professional organization with the world’s leading computational drug development capabilities, we believe that Certara can continue to enable our clients to improve the pace of efficacious drug development for the benefit of patients around the world,” Deieso added.
Certara provides its global pharmaceutical and biotechnology customers with scientific informatics and analytics, including molecular modeling, population-based simulations, pharmacokinetic analyses and clinical trial simulations. Certara has more than 225 employees located at offices in the US, UK, Canada, and Japan.
Based in Wilmington, DE, Synchrogenix is the largest independent regulatory-writing CRO in the world. It has more than 50 permanent regulatory writers and editors on staff, located in seven offices in North America, Europe, and Asia. The company provides pre-clinical, clinical, CMC and drug safety writing, and global regulatory submission services.
“Having worked with our talented staff to build Synchrogenix from the ground up, I was looking for a like-minded company that shared our strong work ethic and focus on excellent customer service and high-quality results. We have found a great match in Certara, and I look forward to expanding the range of services that we offer to all of our customers,” said Synchrogenix CEO Ellen Barrosse. Ms. Barrosse will remain the CEO of Synchrogenix following the transaction.