Purchase adds global regulatory writing and submission services to Certara’s drug development consulting expertise
ST. LOUIS, MO – 2014 年 4 月 15 日 – 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.
Synchrogenix is a specialty contract research organization providing strategic regulatory writing and related services to pharmaceutical, biotechnology, and medical device companies worldwide. The company offers pre-clinical, clinical, CMC, and drug safety writing and submission services. Through its wholly-owned subsidiaries, SynchroWest, Inc.; Synchrogenix Europe Limited; and Synchrogenix Philippines Inc., Synchrogenix provides continuous, global support for its customers.
Certara is the leading technology-enabled drug development and drug safety consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.
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