Strategic Regulatory and Safety Services

Move your product forward—safely—in markets worldwide

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, while our epidemiologists and other drug safety experts deliver the comprehensive research solutions you need to meet your products’ most demanding safety requirements.

For more information, please contact: 1.866.722.6734.

• Global Regulatory Affairs

  
  

  Our regulatory teams based in the United States, Canada, China, and Europe have worked with clients in more than 60 countries address their needs to:

  • Shorten time to market for pharmaceuticals and medical devices
  • Prepare marketing applications in eCTD format across multiple jurisdictions
  • Determine the optimal regulatory strategy for their product
  • Serve as a Canadian agent for clinical trials
  • Ensure compliance with global chemical substance regulations

  
  

  OptumInsight not only offers comprehensive regulatory expertise—it delivers cohesive teamwork that gets results.

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• CMC, Quality and Compliance

  
  

  Leverage the expertise and experience of the Chemistry, Manufacturing and Controls (CMC) and Quality Assurance teams at Optum to:

  • Provide an independent and objective assessment of your dossier
  • Devise strategies to address gaps in your data
  • Manage post-approval reporting requirements globally
  • Release commercial and clinical trial drug supply
  • Assist with Health Canada licensing requirements
  • Perform GMP/GCP/ISO/ICH audits

  
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• Pharmacovigilance

  
  

  OptumInsight provides pharmacovigilance services worldwide for the pharmaceutical industry. Operations are conducted by a team of individuals, including two physicians, six pharmacists, and numerous other pharmacovigilance professionals based in North America, Europe and China.  Our pharmacovigilance clients engage us when they need to:

  • Retain a QPPV in Europe
  • Establish an office in a new country, where they also require regulatory and quality assurance services
  • Prepare application-related safety documents (e.g. for an NDA)
  • Secure 24/7 coverage for medical information services
  • Provide training for their in-house teams

  
  

  Our pharmacovigilance services synergize with OptumInsight’s Epidemiological services.  The United Health claims database is utilized by the FDA in safety surveillance related to its Mini-Sentinel program.  OptumInsight’s Epidemiological Team and Late Phase team can provide registry support, Phase IV safety studies and epidemiological studies based on real life use of medicines.

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• Safety Signal Detection

  
  

  Faster insights about a product’s safety profile can lead to faster actions. Optum AperioLive^TM is a first-in-class safety surveillance tool that leverages OptumInsight’s epidemiological expertise and one of the largest post-launch sample populations to date—our proprietary health care database, which contains the health care experiences of millions of individuals—so that users can monitor the safety of new medical products quickly and effectively.

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• Epidemiology

  
  

  When it comes to drug safety and epidemiology, you want real insights, not just information. OptumInsight epidemiology experts are recognized for their scientific rigor and integrity.

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• Risk Management

  
  

  Develop risk management plans (RMPs), proactively identify and investigate predicted or emerging risks, and conduct studies to assess post-market real-world risk and the effectiveness of risk minimization initiatives (including REMS).

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