Success can create its own set of challenges. Through in-house R&D and strategic acquisitions, this client became a global force, commercializing a series of transformative biologics for rare diseases that simultaneously saved lives, fueled corporate growth, and strained some of the company’s manufacturing procedures.
At their Massachusetts facility, the validation and quality teams do outstanding work. So they understood the magnitude of the challenges they faced after a regulatory audit illuminated several areas that needed attention.
To assist, the company engaged ICQ to provide the expertise and resources needed to ensure compliance and improve procedures, all while working in real time, with live product in production.