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Product Registration Services (Phase II-III) Click here to watch video

PRA's Product Registration group has been instrumental in helping our clients conduct over 650 trials in the last five years and has achieved more than a dozen drug approvals across a range of therapeutic areas, including:

In many cases, partnerships with our clients include dedicated, cross-functional operations centers to support a complete portfolio of candidate drugs. PRA has been successful in helping our clients achieve their goals because of our therapeutic expertise, commitment to quality and the close involvement of our entire project team. Our commitment to quality is reflected in the following areas:

  • The PRA Management System™, our proprietary quality management system that ensures global use of standardized processes and technology
  • A unified, state-of-the-art global Information Technology (IT) infrastructure for ease of communication and access to data
  • Proven therapeutic expertise that includes our own drug development experts, regional key opinion leaders and networks of proven investigators
  • Strong global project leadership with the ability to interact seamlessly across borders—sharing and benefiting from their collective experience
  • People on the ground throughout the world who are intimately familiar with local regulatory requirements for study startup and execution. Local contacts enable us to recruit and sustain program-driven patient populations.