NEWARK, Calif., JULY 30, 2018 — Regulatory Professionals, Inc., has joined Premier Research, a global provider of clinical development services, in a partnership that will offer regulatory solutions to biotechnology, pharmaceutical, and medical device companies. Upon acquiring RPI, Premier Research has created a Regulatory Services Division of Premier Research that will be headed by Donna Kato, RPI’s Founder and CEO.
“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,” Ms. Kato 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.”
RPI provides strategic advice, regulatory planning, and a full range of eCTD 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: 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. “Joining with RPI will expand our ability to help our customers realize the potential of their novel therapies and life-changing innovations.”
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.
RPI was advised by Edgemont Capital Partners, Lowenstein Sandler LLP, and KPMG LLP. 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.
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 www.regprofessional.com
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.