Risk Management Consulting

Quality risk management is critical to regulated company operations. Regulated companies must proactively develop and implement risk management practices to ensure product quality throughout the product lifecycle. Also, strategic management is needed to ensure the drug product’s quality to the patient’s safety and facilitate better and more informed overall decisions to address potential risks.

At Xevalics, we support our clients by strengthening and streamlining their quality risk management system. We bring expertise and experience to adopt risk-based thinking, problem-solving, and continuous improvement approaches across the GxP areas and the product lifecycle. Our expert consultants have the experience to work side by side with your team in developing and implementing risk management tools for risk identification and mitigation (like, Failure Mode Effect Analysis, Fault Tree Analysis, Preliminary Hazard Analysis, Health Hazard Evaluation, among others.)

Xevalics consultants will vigorously assess your quality systems, software, and processes to identify, prioritize, facilitate, resolve, and appropriately escalate and communicate risks and issues. We want to ensure that you can proactively engage and manage your risks following an agile strategic enterprise risk management.

List of Expertise & Capabilities:

  • Quality Systems Risk Assessments
  • Risk Evaluation and Mitigation Strategy (REMS)
  • FMEAs Development and Implementation
    • Planning and Pre-Work
    • FMEA Team Meetings
    • RPNs Evaluation
    • Action Plans Definition and Tracking
    • Follow-Up and Reassessments
  • Risk Register Development and Management
  • Product Risk Management

Let’s Connect

Effective risk management is crucial for patient safety and essential for your company to ensure GxP compliance while meeting the needs of the business objectives. Xevalics has proven negotiating skills to assure actions needed are addressed based on the applicable sense of urgency and to get results faster. Contact Xevalics today and find out which risk management strategies best suit your business needs.