Program and Risk Management

Managing programs, mitigating risk.

A proactive partner focused on compliance, leadership, communication and risk mitigation.

Program management is fundamental to creating high-quality products. Alongside our technology accelerators, which contribute to program acceleration, our quality management system and program management practices enable us to leverage competitive factors for the benefit of our customers.

Quality Management System

We comply with all relevant standards, hold all the necessary certificates and live by all appropriate regulations. These are the minimum expectations that all designers and manufacturers of pharmaceutical and medical devices must meet before taking their product to market. Our true differentiator is how we use quality standards, and how we integrate them into our robust, phase-appropriate project management system. Simplicity is the key to our success. We have streamlined all processes, so they are efficient, effective and easy to use. This is part of the competitive advantage that our customers gain by partnering with us.

We utilize failure mode and effects analysis (Use, System, Design and Process) ahead of development to mitigate risks. During development and manufacturing, we support the appropriate product and process qualification and validation activities. This ensures your product meets the specified requirements and is developed in compliance with all relevant regulations.

Program Management

We operate with a global program management office (PMO). Our program management processes are therefore standardized and have an executive governance process. By applying an integrated program management process that supports a strong emphasis on program planning, critical path management and risk mitigation, we are able to manage programs to on-time completion. We are therefore able to provide customers, wherever they are on the globe, with world-class program leadership spanning from concept development through manufacturing launch.

Program Management and Risk Management Processes We Use:

Clear, concise and transparent communication is a core responsibility of all program leaders.

  • Program plans, timelines and action plans are communicated regularly to customers
  • Program status and risk are transparent to the customer with regular communication
  • Strong program leader communication allows technical resources to focus on technical execution without distraction
  • Program governance is established with functionally paired stakeholders to align the measure of success