Quality Compliance Remediation Services
Regulatory Compliance 黄人导航 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.听 With a proven track record of success, RCA has significant experience with the development of responses to 483 Observations, Warning Letters and Consent Decrees.听 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.听
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
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RCA can provide needed 黄人导航 remediation expertise and services in the following key areas:
- Remediation Services
- Quality Systems听
- Technical File and Design History File (DHF)
- 21 CFR Part 11 & Computerized System Validation
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To begin the Regulatory Compliance 黄人导航 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听You may also email us at [email protected].
