PE-backed Premier Research buys Regulatory Professionals Inc

Premier Research has acquired California-based Regulatory Professionals Inc, a California-based provider of regulatory expertise and solutions to biotechnology, pharmaceutical and medical device companies. No financial terms were disclosed. William Blair & Company provided financial advice to Premier Research while Ropes & Gray LLP served as legal adviser. And, Edgemont Capital Partners, Lowenstein Sandler LLP and KPMG LLP advised RPI. Premier Research is a portfolio company of Metalmark Capital.


DURHAM, N.C., July 30, 2018 /PRNewswire/ — Premier Research, a global provider of clinical development services to biopharmaceutical product innovators, has acquired Regulatory Professionals, Inc. (RPI), a California-based company that provides regulatory expertise and solutions to biotechnology, pharmaceutical, and medical device companies. This partnership will form a new Regulatory Services Division of Premier Research, and Donna Kato, RPI’s Founder and CEO, will become President of the newly created division.
RPI provides strategic advice, regulatory planning, and a full range of submission services, helping its clients advance the development and registration of their products in worldwide markets. Founded in 1995 and based in the San Francisco Bay Area, RPI employs more than 40 professionals with extensive regulatory experience across the complete product life cycle, across product types, and covering a wide range of therapeutic areas that include the largest and fastest-growing such as oncology, neurology, cardiovascular, and dermatology.

RPI’s clients are small and midsize companies seeking guidance and support as they move their products into and through development, as well as larger companies seeking to fill resource gaps within their in-house regulatory departments.

“Taking a new drug or medical device from concept to market requires a thoughtful regulatory strategy, expertly prepared documents for agency submission, and submission management in accordance with increasingly stringent requirements,” said Ludo Reynders, Premier Research CEO. “Most of our clients are specialty pharma and biotech companies that need ready access to development expertise. Joining with RPI will expand our ability to help these pioneers realize the potential of their novel therapies and life-changing innovations. Through our growth in this segment, we have become the CRO that is really built for biotech.”

That focus, Ms. Kato said, makes for a good fit between the companies. “Our ability to create value as a trusted partner and integral member of our clients’ scientific, regulatory, and development teams has earned us a reputation as a strategic adviser supporting regulatory activities in the United States, Canada, European Union, and Japan,” she said. “Combining with Premier Research will give us a much larger footprint and access to resources that complement our regulatory service offering, such as data management and biostatistics, clinical development, safety management, DMPK, and other disciplines important to our clients.”

Premier Research’s principal investor is Metalmark Capital, a leading private equity firm with $3.7 billion in aggregate capital commitments that seeks to build long-term value through active and collaborative partnerships in its focus areas of healthcare, agribusiness, growth industrials, and natural resources.

The investment banking firm William Blair & Company served as financial adviser, and the law firm Ropes & Gray LLP served as legal adviser to Premier Research. RPI was advised by Edgemont Capital Partners, Lowenstein Sandler LLP, and KPMG LLP.

About Premier Research
Premier Research is a leading clinical development service provider that helps biotech and specialty pharma innovators — small companies with big ambitions — transform life-changing ideas into new medicines. The company applies a relentless focus on quality in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical devices, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,250 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts bringing a focus on smart study design for advanced medicines that transform breakthrough biotech thinking into reality. Visit

About Regulatory Professionals, Inc.
RPI was founded in 1995 to serve the growing needs of small to mid-size pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. RPI’s unique ability to create value as a trusted partner and as an integral member of existing scientific, regulatory and publishing teams have earned RPI its reputation as a solutions-oriented advisor. To find out more, visit