In this article, Parexel experts outline five approaches that foreign companies with limited resources should use to gain a foothold in the Chinese market.
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Article from December 2021 edition of Applied Clinical Trials. Parexel regulatory experts offer top tips for working with regulators on a global scale.
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...
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In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.
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Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"
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Parexel Clinical Trial Regulatory Services consultants share what you should be doing now to prepare for the coming changes.
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The science of ethnobridging – a way to implement cost-effective, multi-ethnic approaches to global clinical trial research and drug development.
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Learn about the services and approaches that Parexel Biotech offers to help you make an exponential difference in patients’ lives.
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Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.
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The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...
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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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We have some tips for mapping your strategy
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It’s never too early to start crafting a global regulatory submissions strategy.
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