Audits and Assessments

Regulatory Compliance Associates knows how quality compliance crises can significantly impact your business—and we have the experience to manage those crises. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and compliance assessment solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment or audit.

Audits

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.

  • GMP 6 System Audits
  • Supplier
  • Current Good Manufacturing Practice (cGMP) Compliance Audits
  • Current Good Laboratory Practices (cGLP) Compliance Audits
  • Data Integrity
  • Quality System Compliance Audit
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits

Assessments

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.

  • Current Good Manufacturing Practice (cGMP)
  • GMP Gap Assessments
  • GMP 6 System Assessments
  • International Organization for Standardization (ISO)
  • Quality Infrastructure
  • Corrective and preventive Action (CAPA)
  • Mock Pre-Approval Inspection (PAI)
  • Data Integrity
  • Mock FDA Inspection
  • 503A and 503B

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