Regulatory Compliance Associates Inc. (RCA) is recognized within both the medical device industry as well as the regulatory agencies for its ability to help companies successfully resolve regulatory challenges. With a proven track record of success, RCA has significant experience with the development of responses to 483 Observations, Warning Letters and Consent Decrees. Our value goes beyond the initial response by helping companies successfully execute their action plans, develop a comprehensive program to address it, and ultimately move beyond the regulatory action to emerge as a stronger business.
We will provide a Project Management Professional (PMP) to lead the program, in addition to engineers with expertise in quality systems and manufacturing engineering to execute the program that coordinates with your resources. Every situation is different, and the program’s plan may include aggressive but realistic milestones, as well as supporting tasks, and task dependencies.
Our consultants have experience in FDA-regulated industries and have the expertise to assist you with:
- 483 Response and Remediation
- Warning Letter Response and Remediation
- Consent Decree Remediation
