Regulatory Support
Quality Solutions, LLC understands the complex intersection between regulatory, compliance, operations, facilities and people. We offer a pragmatic approach to addressing regulatory strategies and concerns. We offer strategies that help integrate regulatory requirements in to the product development process. Quality Solutions, LLC staff leverage their experience navigating a variety of regulatory structures and managing the regulatory process. FDA responses, FDA submissions, Remediation Activities, Consent Decrees, 483 Warning Letter Response.

 
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