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Click to learn from RCA's pharmaceutical consultants as they discuss ALCOA and Data Integrity elements to avoid FDA regulatory citations.
Click to read how RCA's regulatory compliance consultants approach investigating & reporting for biologics manufacturing vs. pharmaceuticals.
Click to learn from RCA's regulatory compliance consultants about manufacturing guidelines & regulatory requirements during a pandemic.
The inventor of an objective pediatric vision screener was in need of a quality system surrounding their medical device. RCA…
A pharmaceutical company engaged RCA to prepare the company for an FDA Audit. The company implemented the recommended changes and…
RCA was contracted to develop validation documentation and provide validation services to ensure software was adequately validated and the valve…
A global health care company received an FDA Warning Letter for quality issues with its manufacturing facility. RCA crafted and…
A large global medical device manufacturer received a Warning Letter from the FDA as a result of repeat 483 observations…
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