Regulatory & Access Consulting

Wherever you’re going, our regulatory
and access experts have been there
 

Behind everything we offer at Parexel are teams of people who come to work each day to help you make a difference. Our focus never waivers from the patients waiting for your product and so we have bought together the best minds – an elite team of 1000+ consultants on staff who help our clients chart the best, most-efficient, course through global regulatory, market access and commercial hurdles.

With Parexel’s Regulatory & Access consulting organization you'll get access to industry luminaries, including ~100 Former regulators/HTA Professionals .  Because they wrote the guidance yesterday, we know exactly how to interpret it today.

Bringing together regulatory and market access consulting expertise means that we can help our clients address the requirements of  regulators, providers, payers and patients holistically. This accelerates timelines, reduces risk of delays, and improves efficiency.

Our strategic advisory teams help companies to establish a systematic integration of regulatory requirements, patient engagement, and pricing and market access into the R&D process for better, faster drug development. Because ‘the old way’ just isn’t financially sustainable or effective today.

Our 360-degree insights identify every action possible to reduce the time a patient must wait for an innovative new therapy. Because this is how we make a difference – With Heart.

We have specialized expertise including:

  • ~100 former regulators / HTA assessors
  • Localized knowledge covering 110 countries
  • Industry luminaries with broad experience
  • GxP compliance remediation and mitigation, delivered by former HA inspectors
  • Therapeutic experts with deep technical expertise
  • Market access specialists with proven health technology assessment (HTA) success
  • Communication gurus who know how to position evidence for greater stakeholder engagement
  • Integration with Health Advances, Parexel’s strategic management consulting group

 

Learn more about Regulatory & Access

Learn more about Regulatory & Access

Download our capabilities brochure and learn how we can make a difference. 

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GxP Compliance Consulting

GxP Compliance Consulting

When your production line is someone else's lifeline, we’re here to help.
 

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Preparing for the New Era of Hybrid Regulatory Inspections

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EU Orphan Drug Designation – overcoming regulatory challenges

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8 things you need to know about eCTDs in China

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Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

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New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

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Communicating Value to Providers and Payers

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New endpoints for early-stage cancer are gaining regulatory traction

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Making Expedited Regulatory Pathways Work for Global Drug Development Programs

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Five lessons for building an external control arm that regulators can use

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Three ways to work with the FDA for better patient-focused trials

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Parexel Resource Center

Browse the Parexel Resource Center for our latest content on clinical trial supplies, logistics, innovation, drug safety, cell & gene therapy, and more!

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Communication Preference

Communication Preference