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

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

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  • Solutions for sustainable supply chains in a period of global tumult

    Solutions for sustainable supply chains in a period of global tumult

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

    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?

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

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  • See Parexel's latest COVID-19 expert content

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

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

    In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....

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  • Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...

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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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  • How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance

    How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance

    The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...

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  • It’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too

    It’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too

    In a prior blog post, I wrote about the issue of whether corporate boards of directors could be confronted with the issue of whether they could be held liable for not implementing a...

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  • Interview with Paul Bridges, Head of R&A

    Interview with Paul Bridges, Head of R&A

    If regulatory and payer landscapes are so different, then why bring the two worlds together?

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  • Accelerated Pathways – Alberto Grignolo2:55

    Accelerated Pathways – Alberto Grignolo

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  • Episode 4: Accelerated Regulatory Pathways and Patient Access

    Episode 4: Accelerated Regulatory Pathways and Patient Access

    In this episode, Parexel’s Mwango Kashoki, a former FDA regulator, and Richard Macaulay, who specializes in market access challenges, join Alberto Grignolo to discuss expedited regulatory pathways...

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  • FDA Inspections and Cleaning

    FDA Inspections and Cleaning

    Companies often have many questions concerning their approach to cleaning validation when it comes to preparing for an FDA Inspection.  Often cleaning validation studies are extensively...

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  • Can FDA Really Do That? Understanding FDA’s Jurisdiction

    Can FDA Really Do That? Understanding FDA’s Jurisdiction

    On August 29, 2019 the US FDA sent a Warning Letter to Shanghai Institute of Pharmaceutical Industry (SIPI) (see the Warning Letter).  The FDA charged the firm with refusing a pre-announced...

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  • Rare Disease and Orphan Drug Designations - What You Need to Know

    Rare Disease and Orphan Drug Designations - What You Need to Know

    Collectively, rare diseases affect over 30 million Americans.  The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...

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  • Critical Differences Between a Form FDA 483 and Warning Letters

    Critical Differences Between a Form FDA 483 and Warning Letters

    There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...

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  • Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...

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  • Press announcement: Parexel unveils combined Regulatory & Access consulting organization

    Press announcement: Parexel unveils combined Regulatory & Access consulting organization

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  • Reimagining The Global Value Dossier - Part 6

    Reimagining The Global Value Dossier - Part 6

    A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...

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