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.

Parexel’s Regulatory & Access consulting organization includes ~100 former regulators and HTA assessors.  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 and 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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Four reasons to conduct robust natural history studies before clinical trials

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Maximize the efficiency of regulatory operations with five key competencies

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Five competencies for operational excellence in cell and gene therapy clinical trials

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Crafting a genomics strategy early is key for successful oncology drug development

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The Evolving Cell and Gene Therapy (CGT) Sector in China

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Virtual meetings are easy, right?

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Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

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Understanding the COVID-19 regulatory procedures the FDA is using

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Top 10 Myths About Working with the FDA for an Oncology Drug Approval

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We are always available for a conversation.

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Communication Preference

Communication Preference