Regulatory, Strategies & Submissions

Overcome the obstacles to get products to market faster and smarter.

  • What’s Around the Corner for FDA Inspections?

    What’s Around the Corner for FDA Inspections?

    There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...

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  • Keeping ahead of the regulatory curve – Stay open for business

    Keeping ahead of the regulatory curve – Stay open for business

    On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified...

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  • Biosimilars in the time of COVID-19 and beyond

    Biosimilars in the time of COVID-19 and beyond

    Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

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  • Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...

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  • COVID19 Risk mitigation Services Factsheet

    COVID19 Risk mitigation Services Factsheet

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    Tell Us About Your Biotech Goals.

    What are your top priorities for 2020?
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  • Rare Diseases: Aligning Expertise2:06

    Rare Diseases: Aligning Expertise

    See how Parexel are bringing together regulatory and market access experts to help companies developing rare and orphan disease products. Learn more about our Regulatory & Access Consulting Group: htt

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  • Parexel Regulatory & Access Overview Brochure

    Parexel Regulatory & Access Overview Brochure

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  • Commercial and Regulatory Strategy Considerations for Biotech

    Commercial and Regulatory Strategy Considerations for Biotech

    Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the...

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  • Commercial and regulatory strategy considerations for biotech

    Commercial and regulatory strategy considerations for biotech

    In this blog, Parexel regulatory and strategy experts tackle the question of how we can ensure that worthy innovations in the biotech pipeline make it to patients sooner.

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  • Biosimilars in China: Riding an upward trend

    Biosimilars in China: Riding an upward trend

    In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1].  This biosimilar product, HLX01...

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  • RWE in an evolving regulatory landscape: Using real-world evidence to support novel product development pathways

    RWE in an evolving regulatory landscape: Using real-world evidence to support novel product development pathways

    In this on-demand webinar, Parexel experts discuss the growing interest in RWE from both regulators and payors and the advantages of using real-world data (RWD) to streamline the research process.

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  • What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

    What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

    Drug Master Files (DMFs) may be submitted to the FDA to provide confidential and often proprietary information regarding facilities, processes, or components used in the manufacturing,...

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  • Regulatory Update: Patient Engagement in Drug Development

    Regulatory Update: Patient Engagement in Drug Development

    This month, the FDA released a draft of its second patient-focused drug development (PFDD) guidance document, detailing best practices for understanding patient experiences and the related...

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  • Cell and Gene Therapy & Tissue Engineering

    Cell and Gene Therapy & Tissue Engineering

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  • A Perspective on GMPS Cellular Therapy

    A Perspective on GMPS Cellular Therapy

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  • 3 Ways to Reap Benefits_Adaptive Trials

    3 Ways to Reap Benefits_Adaptive Trials

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  • Strengthen Your Product Value Story One Phase At A Time

    Strengthen Your Product Value Story One Phase At A Time

    Find out how to plan evidence generation for your value story!

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  • Agency Readiness – Bob Iser2:48

    Agency Readiness – Bob Iser

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  • Accelerated Pathways – Alberto Grignolo2:55

    Accelerated Pathways – Alberto Grignolo

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  • Strategies for Working with Global Regulatory Agencies

    Strategies for Working with Global Regulatory Agencies

    Early engagement with regulatory authorities can help boost regulatory success rates and also help shorten clinical development timelines.

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