Regulatory Consulting

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. Click to meet some of our team.

 

Video: Beginning with the end in mind

Video: Beginning with the end in mind

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

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Meet our experts

Meet our experts

Our 1000+ consulting team includes ~100 former regulators, HTA assessors and inspectors. 

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When There Is No Guidance – Navigating Regulatory Meetings With FDA

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What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

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What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products

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Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations

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Tips from FDA – Put Design of Experiments to Use in Drug Applications

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The State of Germline Gene Editing. What We Don’t Know!

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Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?

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RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data

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RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform

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Rescuing Product Approvals from Data Integrity Issues

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Parexel Resource Center

Browse the Parexel Resource Center for our latest content on clinical trial supplies, logistics, innovation, drug safety, cell & gene therapy, and more!

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We are always available for a conversation.

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Communication Preference

Communication Preference