RPI Acquired by Premier Research to Expand Regulatory Offerings

Providing regulatory expertise and solutions to the pharmaceutical, biopharmaceutical, and medical device industry since 1995

Trusted Experience

Trusted Experience

RPI’s collaborative, relationship-oriented approach successfully helps Pharma and Life sciences companies achieve their drug development goals

Customized Approach

Customized Approach

RPI offers strategic and experience-based perspectives to facilitate productive interactions with regulatory authorities

Optimized Resources

Optimized Resources

RPI can complement existing resources and reduces the need for investment in permanent hires

Maximized Value

Maximized Value

The result is expedited drug development time, increased likelihood of regulatory approval, and reduced overall cost for our clients

  • “As a virtual company, relying on external support for operations and regulatory strategy are key to success. RPI is an extension of our small company and is always responsive in meeting our needs. I am particularly appreciative that we and our project needs are given priority with quality. Communications are excellent….I am extremely satisfied with RPI as a key service provider.”

    Dar Rosario Sr. Vice President, Regulatory Affairs and Compliance, Cadence Health, Inc

Headquartered in the San Francisco Bay Area, RPI offers strategic and tactical regulatory expertise in all phases of drug development. RPI’s team of experts leverage our comprehensive submission experience to strategically position and guide clients through a streamlined and customized approach to achieve their drug development goals

About Us

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. Today, we are a highly-qualified and passionate team of experts with deep experience in health authority interactions and in the preparation of complex regulatory submissions requiring specific and strategic regulatory expertise. Our clients range from early-stage start-ups to some of the world’s largest life science companies and encompass all stages of product development, including pre-and post-approval settings. Our unique ability to create value as a trusted partner and as an integral member of existing scientific, regulatory and publishing teams have earned us our reputation as a solutions-oriented advisor providing support for regulatory activities in the US, Canada, EU and Japan.

Our Team

  • “We enjoy working with the RPI staff – very knowledgeable and professional….Top notch service!”

    Jean Pace Associate Director, Regulatory Operations, Portola Pharmaceuticals

Our Services

RPI has successfully helped companies achieve their drug and device development goals since 1995. Our proven track record and hands-on approach allow us to work with clients as part of their trusted team. RPI is uniquely positioned to provide the complete regulatory solution – providing the services of a fully-staffed regulatory department, from acting Head of Regulatory Affairs to specialized regulatory experts – reducing the need and investment for dedicated personnel, as well as supplementing existing resources in times of high need. We have helped hundreds of clients reach their regulatory milestones with highly customized approaches

Regulatory Strategy

RPI regulatory consultants have extensive experience leading and coaching teams in preparation for major submissions and agency meetings. Services include preparation and review of documents submitted to regulatory agencies in support of clinical trials (e.g. CMC amendments, clinical protocols, response to agency questions), review of investigator-site registration packages, document archiving, and record maintenance. Areas of expertise include:

  • Drugs
  • Biologics
  • Devices
  • 505(b)(2)
  • Drug/Device Combinations
  • IVDs, including Companion Diagnostics
  • Orphan Product Development
  • CMC
  • Nonclinical Safety
  • Healthy Authority Interactions

eCTD / Electronic Publishing

With the increasing demand for electronic filing and publishing1, RPI distinguishes itself from other electronic publishing services with RPI’s customized approach, leveraging over 30 years of experience in regulatory affairs. RPI publishers have more than 15 years of publishing and document management experience, including significant experience preparing NDAs, BLAs, DMFs, MAAs, and rest of world submissions, and our goal is not only to guide clients through the eCTD process, but to provide customized expertise at every step of the approval process. In addition, RPI publishers are able to support SPL and electronic datasets through trusted service providers

1Effective May 5, 2017, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) has mandated that New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) be submitted using eCTD format. This requirement for eCTD format submissions extends to Commercial Investigational New Drug Applications (INDs) and Master Files effective May 5, 2018

eTMF / Electronic Trial Master File Management

RPI professionals have significant experience with both paper and electronic Trial Master Files (eTMF) for clinical studies at all stages of development. RPI leverages next generation regulatory content management solutions and facilitates clients’ management of data and documents for clinical trials, providing quality assurance, timely reports, and reconciliations throughout the lifecycle of a study

Clinical Science & Medical Writing

RPI medical writers are technically versed as well as subject matter experts. Our medical writers are seasoned professionals with advanced degrees, who have authored multiple submission documents and co-authored scientific publications. RPI’s clinical science experience enables valuable input into clinical program strategies and plans, more efficient study design along with insightful interpretation of study results

  • “After having worked with RPI for many years now, my expectations were naturally high. Once again, RPI’s outstanding staff delivered, on time, a clean submission. I deeply appreciate RPI’s depth of experience in terms of both regulatory strategy and publishing operations.”

    Jamie Cope VP, Translational Medicine, Reset Therapeutics

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