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.
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• Global Regulatory Affairs

  
  

  No matter what stage of development or where your market, OptumInsight can help you take a rigorous, integrated, strategic approach to global regulatory affairs. Our teams based in the United States, Canada, China, and Europe have worked with hundreds of clients in more than 60 countries to:

  • Shorten time to market
  • Host and publish their IND through the FDA electronic gateway
  • Prepare marketing applications across multiple jurisdictions
  • Build infrastructure and train clients to file their own eCTDs
  • Determine the optimal regulatory strategy for their product
  • Gain a deeper understanding of international requirements
  • Remediate medical device quality systems issues
  • Serve as a Canadian agent for clinical trials
  • Ensure compliance with global chemical substance regulations

  
  

  When millions are at stake, navigating the complex global requirements, trends, and emerging issues is critical. That’s why OptumInsight maintains one of the largest regulatory consulting groups in the world. Our team not only offers comprehensive regulatory expertise—it delivers cohesive teamwork that gets results.

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• Chemistry, Manufacturing, and Controls (CMC) and Pharmaceutical Quality Services

  
  

  Leverage the expertise and experience of the CMC and pharmaceutical quality teams at OptumInsight to:

  • Provide an independent and objective assessment of your dossier
  • Liaise with global regulatory agencies
  • Devise strategies to address gaps in your data
  • Plan for the transition from R&D to commercialization
  • Prepare for regulatory agency inspections
  • Identify opportunities for regulatory relief that provide commercial advantage
  • Manage post-approval reporting requirements globally
  • Support due diligence and licensing
  • Evaluate your API suppliers

  
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• Pharmacovigilance

  
  

  OptumInsight provides pharmacovigilance services worldwide for the pharmaceutical industry.  Joanna Haas, MD, is our Chief Scientist for Pharmacovigilance. 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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