About RCA’s Remediation Services
Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA 483’s, Warning Letters, and Consent Decrees. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company. RCA’s remediation consulting experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute internally. Finally, RCA can partner with your leadership team to develop a long-term risk management plan to help your team stay in compliance going forward.
Regulatory Compliance Associates can assist with answering FDA 483 observations, FDA Warning Letters and developing strategies to help your organization maintain regulatory compliance through continuous improvement.
RCA can help with remediation activities in both manufacturing operations & quality management systems. RCA’s regulatory consultants have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans & help execute. We have also performed post-implementation audits to ensure regulatory compliance.
Follow the links below to learn more about our remediation services in Pharmaceuticals and Medical Devices.
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