Regulatory ProfessionalsRegulatory ProfessionalsRegulatory ProfessionalsRegulatory Professionals
  • About Us
    • Our Story
    • Leadership
    • Senior Consultants
  • Services
    • Overview
    • Regulatory Affairs Strategy
    • Electronic Publishing | eCTD
    • Medical and Regulatory Writing
    • Quality Assurance
    • Project Management
    • Electronic Trial Master File | eTMF
  • Resources
    • Blog
    • White Papers
    • News
  • Careers
  • Contact

News

    Home News

    RPI ACQUIRED BY PREMIER RESEARCH TO EXPAND REGULATORY OFFERINGS

    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.

    Media contact:

    Sarah Tomita
    sarah.tomita@regprofessional.com

    Headquarters

    8000 Jarvis Ave.
    Suite 100
    Newark, CA 94560

    North Carolina

    One Park Drive, Suite 150
    Box 13608
    Research Triangle Park,
    NC 27709

    San Diego

    Aventine Building
    8910 University Center Lane
    Suite 400 San Diego, CA 92122

    United Kingdom

    250 South Oak Way
    Green Park
    Reading, Berkshire, RG2 6UG

    Australia

    Premier Research Australia Pty Ltd.
    Ground Floor, 23 Milton Parade
    Malvern VIC 3144

    • Home
    • About Us
    • Services
    • Cookie Policy
    • Privacy Notice
    • Contact
    Copyright 2020 Regulatory Professionals | All Rights Reserved
    • About Us
      • Our Story
      • Leadership
      • Senior Consultants
    • Services
      • Overview
      • Regulatory Affairs Strategy
      • Electronic Publishing | eCTD
      • Medical and Regulatory Writing
      • Quality Assurance
      • Project Management
      • Electronic Trial Master File | eTMF
    • Resources
      • Blog
      • White Papers
      • News
    • Careers
    • Contact
    Regulatory Professionals
    XWe use cookies (and equivalent technologies) to collect and analyze information on our Website’s performance and to enable the Website to function. Cookies also allow us and third parties to tailor the ads you see when you visit our Website and other third party websites in the same online network, including social networks. By clicking ‘AGREE', you agree to these uses of cookies. If you do not agree or if you would like more information, you can manage your cookie preferences by clicking on 'Cookie Settings'. Cookie Policy REJECTAGREECookie Settings
    Privacy & Cookies Policy

    Privacy Overview

    This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
    Necessary
    Always Enabled

    Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.

    Non Necessary

    Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.

    Save & Accept