MPR Associates, based in Alexandria, Virginia, is a leading nuclear engineering firm that will serve as Coquí Pharma’s engineer, assisting with FDA and cGMP compliance and nuclear engineering and licensing support. For over 50 years, MPR has provided specialty engineering and management consulting to the commercial nuclear power industry, including the areas of quality systems and licensing. In addition, MPR brings years of experience in design, implementation, and validation of unique manufacturing processes for pharmaceutical and radiopharmaceutical products.
MPR’s experience extends to ANSTO’s manufacturing processes. In 2011, ANSTO engaged MPR to conduct an independent assessment of their quality program, along with the processes and practices used in radiopharmaceutical production. MPR’s combination of perspectives from the nuclear and pharmaceutical industries will be invaluable in assuring a well-defined and integrated compliance approach is planned and executed at Coquí Pharma.