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Soma Technology Solutions
Soma Technology Solutions
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  • More
    • Home
    • About
    • AI Driven
    • Services
      • Process Validation
      • Quality Management
      • Pre-Clinical
      • Regulatory
      • Risk Management
      • Data Management
      • Idea To Product
      • Product To Market
      • Market Analysis
      • Digitalization
      • Automation
      • Clinical Trials
    • Industries
      • Biologics
      • Pharmaceuticals
      • Medical Devices
      • Diagnostics
    • Training
      • Training Programs
      • PMinDD Registration

  • Home
  • About
  • AI Driven
  • Services
    • Process Validation
    • Quality Management
    • Pre-Clinical
    • Regulatory
    • Risk Management
    • Data Management
    • Idea To Product
    • Product To Market
    • Market Analysis
    • Digitalization
    • Automation
    • Clinical Trials
  • Industries
    • Biologics
    • Pharmaceuticals
    • Medical Devices
    • Diagnostics
  • Training
    • Training Programs
    • PMinDD Registration

risk management

On average, it takes about 12 years for a life science product to progress from the initial idea stage to being available on the market. This lengthy process demands significant time and resources, which translate to substantial financial investments and inherent risks. Even a minor risk can disrupt this trajectory, resulting in delays and increased costs.

Consequently, it is essential for life sciences and healthcare companies to manage risk effectively. The first step in risk management is identifying potential risks. Addressing these risks requires clear understanding and defined roles for everyone involved in the process. Establishing a robust risk culture begins at the top, with strong leadership and clear direction.


To create an effective risk management infrastructure, responsibilities should be communicated and understood across four levels:

  1. Operational Level: Employees and operators must grasp key risks and their roles in managing them.
  2. Mid-Management Level: Managers should own risks within their areas of responsibility and clearly communicate roles and responsibilities to their teams.
  3. Senior Leadership Level: Senior leaders must accept responsibility for overseeing and managing risks, including compliance matters.
  4. Executive and Board Level: Executives and board members should discuss, prioritize, and manage enterprise-wide risks.


The "Valley of Death" often sees products and technologies fail due to inadequate risk management. Companies encounter various unique challenges as their product life cycles evolve. The ability to effectively identify and mitigate these challenges is a crucial differentiator between success and failure.


SOMA's Risk Management team provides end-to-end risk solutions, developing effective plans to identify and mitigate risks from the initial discovery phase to the final product launch. Our services address several key needs:

  • Strong Product Expertise: Offering customized risk management advice tailored to each product type.
  • Specialized Life Sciences Service Team: Proactively assessing risk profiles in high-growth environments.
  • Adherence to Industry Best Practices: Implementing and replicating successful risk management strategies.
  • Utilization of Key Benchmarking and Actuarial Analytics: Supporting informed decision-making.


With SOMA's comprehensive risk management approach, companies can better navigate the complexities of product development and enhance their chances of success.

@2025 SOMA Solutions.  All Rights Reserved  | Lewisville,  NC 27023 US |  ssomara@somalifesciencesolutions.com   

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