Safely drive your products forward in worldwide markets.
At Optum™, we are diligent, rigorous and comprehensive in our approach to regulatory affairs and compliance.
We maintain one of the largest regulatory consulting groups in the world to help you take a rigorous, integrated, strategic approach to global regulatory affairs. Our epidemiologists and other drug safety experts deliver the comprehensive research solutions you need to meet your products’ most demanding safety requirements. Our go-to team of professionals has the proven experience needed to bring your products to market worldwide.
Global Regulatory Affairs
Our regulatory teams based in the United States, Canada, China and Europe have worked with clients in more than 60 countries. Our diverse project experience ranges from the preparation of marketing applications in eCTD format across multiple jurisdictions, to serving as a Canadian agent for clinical trials, to ensuring compliance with global chemical substance regulations. Optum™ not only offers comprehensive regulatory expertise — it delivers cohesive teamwork that gets results.
Optum™ provides pharmacovigilance services worldwide for the pharmaceutical industry to help them manage the delicate balance between public health, regulatory compliance and the bottom line. Operations are conducted by a team of experienced individuals, including physicians, pharmacists and numerous other pharmacovigilance professionals based in North America, Europe and China.