We offer individual specialists and project teams to assist clients with process design, protocol development, quality improvement, auditing, and operational review to achieve compliance with FDA regulations, CE marking, and other regulatory body requirements. We are particularly well suited for event driven work such as remediation efforts, responses to 483(s), CAPA’s, quality system improvement plans (QSIP), new product releases, and qualifying and validating new manufacturing equipment.
Integrate highly skilled quality engineering professionals to assist you with deliverables (design, development, and manufacturing tasks).
Generate protocols and reports, complete with statistical data analysis.
Quality system and process inspection readiness.
Our skilled individuals can integrate into your company.