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+1 617 454 9300
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+1 919 544 3170
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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:
- Regulatory Strategy & Development Planning
- Regulatory / GMP Compliance
- Regulatory Partnerships
- Clinical Trial Regulatory Services
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.
Visit our COVID-19 Resource Center
Get the latest COVID-19 news, translated guidance information and expert interpretations from our former regulators.
Meet our experts
Our 1000+ consulting team includes ~100 former regulators, HTA assessors and inspectors.
Video: Beginning with the end in mind
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SEE FULL CONTENT STREAM
Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?
Read Now
Points to Consider When Referencing a Master File in FDA Regulatory Submissions (IND, BLA, NDA)
Read Now
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
Read Now
A Long and Winding Road for Transdermal Products – FDA Has It Covered
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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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