Domain Areas

Regulatory Affairs

Develop optimized processes and integrated RACI for global and regional regulatory operations increasing efficiency and compliance while adapting to an ever changing regulatory environment

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Biopharma companies are facing an increasingly dynamic and complex regulatory environment, especially given evolving regulations in emerging markets, recent uncertainty surrounding US regulations, and an overall heightened focus on data. Companies are looking for new operating models that allow them to break down internal silos, leverage data more effectively and increase their use of global partners to reduce investments in fixed assets. TriRadial works with Regulatory groups to assess and improve their global capabilities. Technology is playing a significant role in the evolution of regulatory operations across the industry. We help companies develop future-state architectures and navigate the wide array of vendors in the market that are targeting RIM, IDMP and other data-driven solutions. We also assist in the development of outsourcing strategies and how to optimize global partnerships with regulatory service vendors.

Click here for more information on our Solutions and Capabilities

Example Projects

  • Capability Assessment and Gap Analysis
  • Benchmarking Against Leading Practices
  • Process Optimization and Global Harmonization
  • Quality System Assessment and Remediation
  • Technology Assessment
  • Metrics and Dashboard Development
  • Outsourcing Strategy and Partnership Optimization
  • Structured Content Authoring Solutions
  • Next Generation Monitoring Solutions
  • Organization and Team Design
  • Change Management for Large-Scale Transformations

Let us know how we can help you improve your Regulatory capabilities. Click here to Contact Us