Goals

Achieve the optimal level of quality by balancing the expectations of customers and regulators while achieving a competitive edge and increasing shareholder value.

Solutions

Our solutions include setting up systems to achieve the optimal levels of compliance while balancing costs. We assist organizations in engineering  compliance processes to ensure long-term sustainability in regulatory areas. We also conduct remediation activities to help our clients become compliant.

Outcomes

Assessments for Compliance and Optimization

Develop quality improvement roadmaps

Quality management system assessments to identify systemic issues that can cause risk of non-routine quality events to occur.

Assess the processes for opportunities for optimization

Help with 483 observations, warning letters, consent decree

Quality systems remediation activities

Assessing technology for solutions to move from paper based to digital solutions for quality system controls and processes.

Providing resources to handle the scale up and down of resources for on-going day to day projects.