EU Orphan Drug Designation – overcoming regulatory challenges
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The FDA has strengthened its use of remote inspection and integrate desk-based assessments with traditional on-site visits. This outlines what you need to know about this new era of hybrid inspections
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Although eCTDs are a huge step forward for standardization in the Asia Pacific, there are several important things you need to know before you submit your dossier electronically.
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See Parexel's latest COVID-19 expert content
View allWhile COVID-19 disrupted business operations, the importance of data integrity in manufacturing has not diminished. How can sponsors reconcile the adaptations they made during the emergency?
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David Brown, Global Head of Epidemiology, summarizes the three FDA guidances related to data sources, data standards, and regulatory considerations in RWE/RWD and benefits of early engagement.
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Read their biosRead five ways biotech companies can enhance their value story with advanced analytics.
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For payment systems to evolve to deal with reimbursement and market access challenges, payers are taking a new look at evidence generation and data usage. Read how pragmatic trials can help >
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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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Articulating a coherent product value story from the start of development can help companies attract investors.
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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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Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.
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Useful practices for getting the most out of your collaboration the FDA
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In this article, Parexel regulatory outsourcing experts explore five competencies companies can use to manage post-marketing regulatory requirements better and more efficiently.
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Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.
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