Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing Warning Letters, Consent Decrees, and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance to the regulations.
Our Pharmaceutical Remediation Strategy & Support services are organized to help you deal with circumstances as they unfold. We help you to understand broad implications of your specific situation and layout a remediation strategy acceptable to the regulatory agency. We can partner with you to manage plan execution and to help you stay in a compliant state going forward. Representative services we offer include: