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EU Orphan Drug Designation – overcoming regulatory challenges

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Preparing for the New Era of Hybrid Regulatory Inspections

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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8 things you need to know about eCTDs in China

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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Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

While 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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New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

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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Communicating Value to Providers and Payers

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Early planning can help you make the most of expedited regulatory pathways

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How biotechs can strengthen their value story with advanced analytics

Read five ways biotech companies can enhance their value story with advanced analytics.

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Pragmatic Trials: Targeting evidence generation to inform market access and meet payers’ needs

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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New endpoints for early-stage cancer are gaining regulatory traction

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Five lessons for building an external control arm that regulators can use

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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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Three strategies for articulating a coherent product value story

Articulating a coherent product value story from the start of development can help companies attract investors.

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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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What to know about FDA INTERACT meetings

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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Three ways to work with the FDA for better patient-focused trials

Useful practices for getting the most out of your collaboration the FDA

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Maximize the efficiency of regulatory operations with five key competencies

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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Four reasons to conduct robust natural history studies before clinical trials

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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