Clinical Trial Regulatory Services

Applications when everything must go right.

Our Clinical Trial Regulatory Services team can help facilitate a seamless experience no matter where in the world you operate. By combining centralized data management with the ability to simultaneously manage multiple regulatory submissions, we can guide you through quicker trial start-up and follow-through.

We are also proud to ease your journey with labelling services in a single location. So whether you need a single label or a full library, we can work it into your full-service clinical trial management solution.

Partner for greater flexibility

Across your clinical development journey, consider our Clinical Trial Regulatory Services a hub for all. Whether you, a third party, or Parexel are managing your clinical trial, our processes and solutions are designed to bring everyone together. From your submission plan, assembly, and application management through delivery to master archiving, you’ll rest easy knowing all your assets are being managed by a single watchful team.

Enhance your Parexel experience!

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FDA Releases Long-Awaited Guidance on 3-D Printed Products

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Regulatory & Commercial Guidance on PDUFA VI: Interpretation, Strategy & Implementation

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FDA Revises Surveillance Inspection Program, Implements New Communication Timelines, and Clarifies Roles and Responsibilities

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ICH Q12 to Step 2, Regional Publication to Follow

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EMA Updated First-in-Human Guidance Effective February, 2018

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