Relentlessly identifying every action possible to help reduce the patients’ wait for your therapy.

With Heart

Our 1000+ strong consulting team includes ~100 former regulators/HTA assessors, alongside industry luminaries, who know exactly how to help you navigate regulatory and access hurdles to reach patients sooner.

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Strategies for cell and gene therapies

The cell and gene therapy (CGT) era promises to make life-changing drugs more accessible to patients worldwide. Yet, only a few have gained approval to date. Parexel’s consulting experts, including former regulators provide unique insight into the four most significant challenges companies need to address to accelerate product development.

  • Avoiding regulatory and CMC pitfalls
  • Understanding patient needs
  • Communicating about clinical trials
  • Demonstrating value

Passionately guiding you through a regulatory and access environment they helped shape.


"With unrivaled real-world experience and a collective resume unlike any other team in the industry, our elite group can help you identify and navigate the requirements of regulators, providers, payers and patients holistically, and early. So you can get your innovation from the lab to the people who need it most, faster – with heart."

Paul Bridges
Senior Vice President and Worldwide Head of Regulatory & Access, Parexel 


Unrivaled real-world expertise includes:

  • 1000+ strong consulting team with ~100 former regulators and HTA assessors
  • Localized knowledge covering 110 countries
  • Therapeutic experts with deep technical expertise
  • Market access specialists with proven health technology assessment (HTA) success

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Learn more about Parexel Regulatory & Access Consulting services