It is imperative for Life Sciences companies to look at improving the performance of Quality Management Systems especially in a time of economic pressures for reducing cost and maintaining a competitive advantage.


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


Successfully achieving an optimum level of quality requires a top down, proactive approach. One of the first steps requires the establishment of a roadmap to optimize the quality management system. This roadmap will reduce cost and provide a competitive advantage for the company.  Establishing a prioritization of improvements that provides a quick return on investments while continuing to move toward an optimum state for the long term is essential for success.

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.