Pharmaceutical services company i3 has expanded its regulatory compliance services through the recent acquisition of Canada-based regulatory affairs consulting firm CanReg. Neither company would comment on the financial terms of the deal, which was completed on December 1, 2009.
i3, which is a division of Minnesota-based Ingenix, will add CanReg to its contract research organization (CRO) business, i3 Research—one of six business units within company. CanReg founder and president Anne Tomalin and all CanReg staff will continue to work as employees of i3 and operate under the new business name, i3 CanReg, within the i3 Research business unit.
“I started CanReg in 1996 as one individual—as a small, private company. We’ve grown to be about 110 people, and we’ve done that without a huge amount of resources behind us. As we join i3, what I would look to for the future is the ability to grow and strengthen around the world, internationally, to be able to support that global registration,” Tomalin said. “Regulatory is really the focus of the CRO industry. And having strength in that area brings tremendous strength to a company ...We’ve looked around for other companies that are the size of us in the regulatory arena, and we can’t find any. Even though we’re a small company—or we were a small company before December—we’re still the largest regulatory company.”
As of November, CanReg had more than 350 active clients and held registrations in 60 countries, Tomalin said.
i3 Research’s regulatory services group helps sponsors interact with regulatory agencies and prepare and submit drug applications that meet regulations and guidelines. The company has regulatory submission experience in more than 50 countries.
“We still had individuals that provided regulatory support [before the CanReg deal], but they were limited in number,” said i3 Research President Tracy Tsuetaki. “What CanReg brings to us is some additional skill sets that extend even beyond pharmaceuticals and biologics. CanReg also has done work in the areas of medical devices and diagnostics as well. They have been involved in terms of serving the needs of conducting due diligence on the regulatory side for law firms, venture capitalists. Most importantly, what they bring to us is expertise.”
i3 delivers contract research services in 56 countries and is therapeutically focused on oncology, the central nervous system, respiratory, infectious and pulmonary diseases and endocrinology.