At Regulatory Compliance Associates® Inc, our team of experts can assists Law firms in helping their clients with regulations, quality protocols, operation efficiency, getting products to market, federal acquisition regulation by executing due diligence, as well as GMP and GCP remediation enforcement responses.

 

RCA® Inc. has been an Expert Witness for clients providing product regulation compliance and quality for pharmaceutical and medical device operations. As an Expert witness, we can ensure that you and your clients have the right expert for each case.

 

RCA® Inc. can help your client that either has to remediate a problem that they’ve self-identified or a problem that a Health Authority (ex: FDA) has identified in an inspection. We have the ability to get you the help you need within the tight response window each regulatory body provides.

 

We can also provide assistance with transitioning to new or updated regulations such as the European Medical Device Regulations (EU MDR), In-vitro Diagnostic Regulations (IVDR), and the European territorial cooperation (ETC).

 

 

 

 

Since 2000, thousands of companies across the world have trusted RCA® Inc. to care for their unique regulatory compliance needs. Our expertise is backed by more than 500 professionals, including FDA veterans and other subject experts who are here to guide you through every step of the regulatory compliance process. Whether you’re a Fortune 100 company or a small enterprise, trust RCA® Inc. to partner with you to tailor an ideal compliance services solution.

 

Additional Blog Updates

 

FDA Publishes Updated Biologics Guidance

FDA Publishes Updated Security Guidance

FDA Expands Virtual Audit Guidance

FDA Guidance on Product Lifecycle Management

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