Regulatory & Access Consulting

Expertise to optimize and accelerate development at every step.

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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Regulatory approval and reimbursement are two completely different worlds, but are they?

 

If regulatory and payer landscapes are so different, then why is Parexel bringing two completely different worlds together? Paul Bridges, SVP of Parexel’s newly formed business explains.
 

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Covid-19 Health Authority Updates

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Solutions for sustainable supply chains in a period of global tumult

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COVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives

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Desk-based Health Authority inspections: A risk-based approach to compliance

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Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

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Bioprocessing and Biologics risk from Coronavirus

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CAR-T: How far have we come and where are we going?

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Rare Diseases: Aligning Expertise

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Accelerated Pathways – Alberto Grignolo

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Rescuing Product Approvals from Data Integrity Issues

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We are always available for a conversation.

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