Global Planning

Global Planning

Global reach. Local Expertise.

How emerging biotechs can enter the Chinese market and prosper

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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Making Expedited Regulatory Pathways Work for Global Drug Development Programs

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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Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial.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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Biosimilar Development: Are therapeutic clinical trials needed?

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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Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"

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Six top tips to prepare for the new EU Clinical Trial Regulation

Parexel Clinical Trial Regulatory Services consultants share what you should be doing now to prepare for the coming changes.

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Can Chinese Phase I data from the West accelerate China drug development?

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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Parexel Biotech Brochure

Learn about the services and approaches that Parexel Biotech offers to help you make an exponential difference in patients’ lives.

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Top 10 Myths About Working with the FDA for an Oncology Drug Approval

Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.

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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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What To Consider When Submitting An Application To The National Drug Administration of China

We have some tips for mapping your strategy

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Strategies for Working with Global Regulatory Agencies

It’s never too early to start crafting a global regulatory submissions strategy.

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