Certara buys CRO Synchrogenix as regulatory writing sees more outsourcing

By Zachary Brennan

- Last updated on GMT

Certara buys Synchrogenix as regulatory writing sees more outsourcing
Consultancy and drug developer Certara has acquired specialty contract research organization (CRO) Synchrogenix Information Strategies, which offers regulatory writing and related services to biopharma and medical device companies worldwide. 

Financial details of the acquisition were not disclosed.The acquisition comes as the market for outsourced regulatory writing is seeing more growth, Certara spokeswoman Lisa Osborne told Outsourcing-pharma.com

The regulatory writing market is on the upswing as more biopharma and medical device companies are outsourcing these services​,” Osborne said. “There’s a shortage of employees with the requisite background as it’s a highly specialized niche market.”

The acquisition will combine Delaware-based Synchrogenix, which is the largest independent regulatory-writing CRO in the world, with Certara, which offers 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.

Synchrogenix 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.

The acquisition occurred now as Certara was looking to expand its small regulatory writing team in Montreal more globally, Osborne said. The two companies also have overlapping clients, but they’re dealing with different individuals in the groups. The objective is to synchronize those discussions into a more continuous process for the client, she said.

 “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​,” Donald Deieso, Chairman of Certara, added.

Related topics: Commercial Services, Regulatory affairs

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