Our associates have nearly two and a half decades of experience as Life Sciences industry professionals, providing third‐party oversight, process development, process improvement, change management, business planning and computer systems validation experience to healthcare and pharmaceutical companies that are either facing or are under a Consent Decree.
Our diverse experience, which also includes coaching, mentoring and team building in a GxP environment, has enabled our clients to successfully address regulatory challenges and operate in a more streamlined, compliant and cost-effective manner while increasing their own workforce’s intellectual knowledge.
More specifically, we have successfully provided the following services:
• Implementing key performance indicators for compliance to focus the expenditure of funds for continuous improvement (cost of quality)
• Providing independent auditing capability to ensure Quality Management systems that provide a high degree of assurance of data management
• Creating and implementing Disaster Recovery and business continuity processes
• Automation and cloud base application support to reduce operating cost variability while increasing existing manufacturing capability