275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2021. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2021. Parexel International Corporation.
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:
Download or capabilities brochure and learn how we can make a difference.
Get access to our latest content, translated guidance information and expert insights designed to help companies navigate complex regulatory and market access hurdles.
Noreen Lynch
noreen.lynch@parexel.com
The Evolving Cell and Gene Therapy (CGT) Sector in China
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Set Your Organization and FDA Up for Compliance Success in Shifting Times
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Patient engagement: Being heard
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The Evolving Cell and Gene Therapy (CGT) Sector in China
Read Now
Set Your Organization and FDA Up for Compliance Success in Shifting Times
Read Now
Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions
Read Now
Virtual meetings are easy, right?
Read Now
Parexel on the Pulse
Watch Now
Navigating the new normal for meetings – now and for the future
View Now
The long and winding road for quality metrics takes another turn
Read Now
Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products
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Patient engagement: Being heard
Watch Now
Five points to remember if FDA issues a Form 483
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Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic
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When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases
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How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House
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The impact of COVID-19 on clinical trials in rare disease and oncology
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Hong Kong Exchange: Nurturing China’s Biotech Valley
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How to interact virtually with health authorities
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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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FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
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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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Putting the Pandemic in Plain Language
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Navigating new steps in how FDA is managing COVID-19 Products
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How COVID-19 is Accelerating Telemedicine Adoption in Asia Pacific
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COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials
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Part Two: The Unique Impact of COVID-19 and Implications for the MSK Industry
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The Great Lockdown of 2020: Will the Life Sciences Emerge Unscathed?
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Back to the future – Are you prepared to meet unprecedented demand to use old drugs for new purposes?
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Solutions for sustainable supply chains in a period of global tumult
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CAR-T: How far have we come and where are we going?
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FDA Inspections and Cleaning
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Does FDA Consistently Assess Product Quality Risk and Control in Applications?
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We are always available for a conversation.