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

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

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Meet our experts

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

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Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?

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Points to Consider When Referencing a Master File in FDA Regulatory Submissions (IND, BLA, NDA)

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Points to Consider for Establishing Biotechnological/Biological Product Comparability

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Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products

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FDA & EMA Joint Report on Early Access Pathways

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A Long and Winding Road for Transdermal Products – FDA Has It Covered

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Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

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Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

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Rescuing Product Approvals from Data Integrity Issues

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Biosimilars in China

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We are always available for a conversation.

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