To RESTORE compound or other personalized medicine quality, regulatory compliance, or operational excellence.

Solution-focused 503As, 503Bs, cell & gene labs and other personalized therapeutic focused GMP companies that want to stay ahead of regulations or respond to quality or compliance insufficiencies.

RESTORE is investigative & corrective consulting that includes: a root cause investigation or gap analysis audit, CAPA plan, and regulatory response or summary report. Some clients may opt or require additional advisement such as fractional leadership, training, continuing education, SOP customization, facility renovation, accreditation, licensing, probationary monitoring, or expert witness services.