RCA was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing…
Click to learn how RCA's FDA consultants helped a client respond to FDA 483 and warning letters to address quality…
A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document change process.
A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective…
A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product lifecycle.
Click to read how RCA's medical device consultants developed strategies to help a client respond to a critical FDA 483…
Click to learn how RCA's medical device consultants helped a client with ISO certification through design history file (DHF) remediation.
Click to learn how RCA's regulatory compliance consultants helped a medical device client with sample validation & shelf stability testing.