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 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
  • 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

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

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Visit our COVID-19 Resource Center

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Get the latest COVID-19 news, translated guidance information and expert interpretations from our former regulators.

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The impact of COVID-19 on clinical trials in rare disease and oncology

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Regulatory & Access: Local knowledge

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The Move Toward Global Standards: Navigating New EAEU Guidelines

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An overview of the recent Executive Order on Critical Drugs Made in America

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I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

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eBook: Biopharma in the COVID-19 World

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

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NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

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Will the FDA “CARE” More About Your Supply Chain?

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GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

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We are always available for a conversation.

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