Premier Research acquires CA-based firm to develop regulatory services division

30-Jul-2018 - Last updated on 31-Jul-2018 at 15:17 GMT

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Premier Research has acquired Regulatory Professionals, establishing a new regulatory services division in response to customer demand.

Premier Research is a private equity (PE) backed contract research organization (CRO) operating in 84 countries. San Francisco, CA-based Regulatory Professionals Inc. (RPI) provides regulatory expertise to a range of companies including biotech and pharma.

Premier Research chief commercial officer Sean Russell told us the acquisition provides “significantly more resources for our customers in terms of being able to provide them with very early regulatory strategy.”

Based in the Bay Area, RPI gives Premier a “California hub,” which Russell said is “very important” as several of its biotech customers – and potential new customers – are based in the area.

The companies will integrate to establish a regulatory services division within Premier, which Donna Kato, RPI CEO and founder, will lead.

“RPI has 47 employees [who] will become part of our Regulatory Services Division,” said Russell. “We have five regulatory people in Premier focused on IND [investigational new drug] strategy. They will become part of the Regulatory Services Division.”

The new division will enable customers to engage with US and European regulatory agencies. The CRO will be able to handle IND work from preparation and maintenance through clinical development, Russell explained. The company also will provide resources for new drug (NDA) strategy, prep, and filing.

“The bulk of our business comes from biotech, and what RPI does for Premier is provide significantly greater resources,” Russell said. “We’ve been experiencing very strong demand from customers and regulatory strategy is often the first thing that biotech companies need just to help them navigate the regulatory field both in the US and Europe.”