Navigate Regulation

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.

CMC, Quality and Compliance

Optum has teams dedicated exclusively to chemistry, manufacturing and controls (CMC), pharmaceutical quality assurance, medical device quality systems and clinical compliance (GCP). These regulatory and quality specialists provide support to our clients around the world.

Pharmacovigilance

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.

Safety Signal Detection

Faster information about a product’s safety profile can lead to faster actions — keeping consumers safe. Optum™ AperioLiveTM is a first-in-class safety surveillance tool that leverages our epidemiological expertise at Optum.

Epidemiology

When it comes to pharmacoepidemiology, you want real insights, not just information. Optum™ epidemiology experts are recognized worldwide for their scientific rigor and integrity. We’ll help you get a deep understanding of the patients who will ultimately use your products.

Risk Management

The experts at Optum™ can help your organization develop and implement a comprehensive risk management approach throughout the product lifecycle.

PASS/PAES Trials

PASS and PAES trials can be resource-intensive and often involve a large number of patients, sites and countries; follow-up periods of 10 years or more are not unusual. Optum™ is well-versed in successfully conducting PASS/PAES trials as part of our overall late-phase service offering.