Compliance Assurance

RCA leverages a risk-based assessment methodology to evaluate your organization’s current compliance posture. Whether you’re seeking to gauge FDA inspection readiness or identify gaps within your Quality Management System (QMS), RCA delivers actionable insights to support continuous improvement and regulatory alignment.

Using a risk-based audit approach, RCA helps pharmaceutical companies assess the health of their quality systems and overall state of compliance. Whether you’re preparing for an FDA inspection, a PAI, or simply conducting a routine internal audit, RCA provides deep industry expertise to identify compliance gaps, ensure alignment with current GMP expectations, and reduce regulatory risk.

RCA can assist in developing a response that will be accepted by the Agency and be realistic for your organization to execute. We can prepare a strategy and implementation program to help remediate the observations as well as develop a comprehensive proof book. RCA can also provide independent oversight of your operations during the remediation efforts to help mitigate the impact to on going business.

Hope is not a strategy when it comes to Audit and compliance training for an FDA inspection. RCA can help your team prepare for inspections, manage inspections, and remediate adverse findings. We have a training program that suits your professional needs, company goals, and preferred learning style.