Global Regulatory Affairs

Our regulatory consulting team serves clients around the globe—from biotech startups to large pharma—as well as the research, investment, and legal firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 120 professionals and staff. OptumInsight has dedicated teams for each of the following practice areas.

  • US regulatory affairs
  • Canadian regulatory affairs
  • European regulatory affairs
  • China regulatory affairs
  • Medical devices and quality systems
  • Environmental regulatory affairs
  • Natural health products
  • Regulatory operations/publishing
  • Scientific affairs

Highly knowledgeable OptumInsight global regulatory specialists combine a nuanced understanding of regional regulatory environments with in-depth functional expertise in areas from best practices to training. Whether it’s helping you build major electronic submissions or efficiently manage day-to-day issues, we offer you proven expertise and reliable project management.

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Case Studies & Insights

Regulatory Case Studies Read more.


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China-based Regulatory & Clinical Support Services Download PDF.

Medical Device Regulatory Services Download PDF.

Environmental Regulatory Solutions Download PDF.