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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…
Learn how RCA regulatory compliance consultants helped a medical device client develop a protocol for Endotoxin control & surgical needles.
A suitable cleaning and disinfection process needed to be validated as safe and effective, and a regulatory analysis was needed…
Wanting to purchase a medical enterprise, a private equity firm contacted RCA to perform a technical due diligence analysis of…
The medical device company received an FDA warning letter and sought RCA's guidance to create a response and remediation strategy.…
A global manufacturer of pharmaceuticals was facing potential expiration of a substantial quantity of API when their API manufacturer suddenly…
A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. RCA suggested a CBE 30, which…
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