Case Study: Warning Letter Remediation

RCA Radio

Oct 12 2021 • 11 mins

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Executive VP of Pharmaceuticals, Steven Lynn go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations.

Listen in as we break down the client's Warning Letter Remediation challenges, RCA's approach to remediation, the ongoing work still taking place, and some advice on FDA Investigation Readiness. Stay tuned for Part 2 of this case study once we have completed the entire project.

About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.