Global Regulatory Consulting

Industry leaders with comprehensive submission experience to strategically position your product.

Guiding you from phase to phase

Overview

Regulatory guidelines are complex and ever-changing. Understanding the regulatory landscape is a key first step to a successful clinical program. At Premier Research, our Premier Consulting regulatory experts are frequently engaging with regulatory authorities to support a wide range of regulatory services. They can seamlessly integrate with your team or fully manage your regulatory needs — from preparing and reviewing submission documents to securing expedited development designations and offering strategic guidance for pathway selection, submissions and interactions with global health authorities.

We’ll assess the unique opportunities and challenges of your program along with the demands of the regulatory landscape to design a successful approach, giving you confidence in the strategic positioning of your program.

Regulatory consulting

  • Extensive experience with agency interactions, averaging 75-plus meetings per year
  • Consulting services aligned with agency thinking on drug, biologics, device, and diagnostic development requirements
  • Functional services such as acting head of regulatory for start-up companies
  • Preparation and review of clinical protocols, CMC amendments, and response to agency questions
  • Commercial solutions that maximize the potential of your program throughout development and the commercial lifecycle
  • Publishing and document management experience, including significant work with new drug applications, biologics license applications, marketing authorization applications, medical device and diagnostics approvals/clearances, and rest-of-world submissions

Preparing customers for major submissions and agency meetings

The experienced Premier team can develop your:

  • Strategic development plans
  • FDA and EU Notified Body meeting preparation
  • Nonclinical program
  • IND/IDE and marketing application preparation and submission
  • Orphan drug, breakthrough, and fast-track applications
  • Clinical study design
  • Clinical study reports
  • Global safety database design
  • SAE reporting

Customized development strategies

From early-phase to late-stage development, Premier’s global product development team leaders synchronize multidisciplinary services, global development expertise, and insight from therapeutic thought leaders to create development strategies custom-fit to your needs.

resources

Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.

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