Regulatory

Start your regulatory journey on the right foot.

The final stretch of regulatory submissions can seem murky – especially when that path takes you through the requirements of multiple countries. Every one of our 1000+ regulatory consultants across 110 countries share a deep understanding of intricate regulatory requirements and a sense of urgency to get important therapies to those who need them. In fact, many of them are former regulators themselves.

Working together, our regulatory consulting services empower you to maintain control of your pathway and stay ahead of any compliance risks. With practical interpretation, we help you understand how guidelines around the world apply to you – including in expanding markets like China.

Our services include:

Meet Our People

With Parexel, a seasoned advisor is always close by and ready to guide your molecule to market, including strategic compliance experts and former FDA, EMA and NMPA employees:

Video: Beginning with the end in mind

Understand how Parexel's Regulatory Services can help you navigate regulatory complexities

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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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We are always available for a conversation.

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